Repurposed Drug Database


Idoxuridine

Original Indication
Treatment of keratitis caused by the virus of herpes simplex.
New Indication
Treatment of nonparenchymatous sarcomas.

Imciromab pentetate

Original Indication
A cardiac imaging agent for detecting the presence and location of myocardial injury in patients with suspected myocardial infarction.
New Indication
Detecting early necrosis as an indication of rejection of orthotopic cardiac transplants.

Interferon beta-1a (recombinant human)

Original Indication
Treatment of relapsing forms of multiple sclerosis to slow the accumulation of physical disability and decrease the frequency of clinical exacerbations.
New Indication
For the systemic treatment of cutaneous T-cell lymphoma.

Interferon beta 1b (recombinant)

Original Indication
In ambulatory patients with relapsing-remitting multiple sclerosis to reduce the frequency of clinical exacerbations.
New Indication
Treatment of acquired immunodeficiency syndrome.

Ketoconazole

Original Indication
Treatment of the following systemic fungal infections: candidiasis, chronic mucocutaneous candidiasis, oral thrush, candiduria, blastomycosis, coccidioidomycosis, histoplasmosis, chromomycosis, and paracoccidioidomycosis.Ketoconazole It's also indicated for the treatment of patients with severe recalcitrant cutaneous dermatophyte infections who have not responded to topical therapy or oral griseofulvin, or who are unable to take griseofulvin.
New Indication
For use with cyclosporine A to diminish the nephrotoxicity induced by cyclosporine in organ transplantation.

Lapatinib

Original Indication
TYKERB, a kinase inhibitor, is indicated in combination with: (1)capecitabine, for the treatment of patients with advanced or metastatic breast cancer whose tumors overexpress HER2 and who have received prior therapy including an anthracycline, a taxane, and trastuzumab. (2)letrozole for the treatment of postmenopausal women with hormone receptor positive metastatic breast cancer that overexpresses the HER2 receptor for whom hormonal therapy is indicated.
New Indication
Treatment of ErbB2 positive gastric cancer.

Leflunomide

Original Indication
Indicated in adults for the treatment of active rheumatoid arthritis:1. to reduce signs and symptoms 2. to inhibit structural damage as evidenced by X-ray erosions and joint space narrowing 3. to improve physical function.
New Indication
Prevention of acute and chronic rejection in patients who have received solid organ transplants.

Levocabastine HCl ophthalmic suspension 005%

Original Indication
Temporary relief of the signs and symptoms of seasonal allergic conjunctivitis.
New Indication
Treatment of vernal keratoconjunctivitis.

Levofloxacin

Original Indication
Treatment of adults ( 18 years of age) with mild, moderate, and severe infections caused by susceptible strains of the designated microorganisms in the conditions listed in the label.
New Indication
Treatment of pulmonary infections due to Pseudomonas aeruginosa and other bacteria in patients with cystic fibrosis patients.

Mannitol

Original Indication
Mannitol Injection is indicated for: Promotion of diuresis, in the prevention and/or treatment of the oliguric phase of acute renal failure before irreversible renal failure becomes established. Reduction of intracranial pressure and treatment of cerebral edema by reducing brain mass. Reduction of elevated intraocular pressure when the pressure cannot be lowered by other means. Promotion of urinary excretion of toxins.
New Indication
For use to facilitate clearance of mucus in patients with bronchiectasis and in patients with cystic fibrosis at risk for bronchiectasis.

Mazindol

Original Indication
Used as a short-term supplement to diet and exercise in the treatment of obesity.
New Indication
Treatment of Duchenne muscular dystrophy.

Medroxyprogesterone acetate

Original Indication
Treatment of secondary amenorrhea and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as fibroids or uterine cancer.It is also indicated to reduce the incidence of endometrial hyperplasia in nonhysterectomized postmenopausal women receiving daily oral conjugated estrogens 0.625 mg tablets.
New Indication
Treatment of immune thrombocytopenic purpura.

Mepivacaine

Original Indication
Indicated for production of local or regional analgesia and anesthesia by local infiltration, peripheral nerve block techniques, and central neural techniques including epidural and caudal blocks.
New Indication
Treatment of painful HIV-associated neuropathy.

Mesalamine

Original Indication
Maintenance of remission of ulcerative colitis in patients 18 years of age and older.
New Indication
Treatment of active, mild to moderate ulcerative colitis in children 5 to 17 years.

Zidovudine

Original Indication
Cancer.
New Indication
HIV/AIDS.

Topiramate

Original Indication
Epilepsy.
New Indication
Obesity.

Topiramate

Original Indication
Epilepsy.
New Indication
Irritable bowel syndrome.

Tofisopam

Original Indication
Anxiety-related conditions.
New Indication
Irritable bowel syndrome.

Tofisopam

Original Indication
Anxiety-related conditions.
New Indication
c AMP modulation by PDE4 inhibition.

Tadalafil

Original Indication
Inflammation and cardiovascular disease.
New Indication
Male erectile dysfunction.

Sildenafil

Original Indication
Angina.
New Indication
Male erectile dysfunction.

Sibutramine

Original Indication
Depression.
New Indication
Obesity.

Ropinirole

Original Indication
Hypertension.
New Indication
Restless leg syndrome.

Raloxifene

Original Indication
Osteoporosis.
New Indication
Breast and prostate cancer.

Phentolamine

Original Indication
Dermal Necrosis (hypertension).
New Indication
Autism.

Paclitaxel

Original Indication
Cancer.
New Indication
Restenosis.

Minoxidil

Original Indication
Hypertension.
New Indication
Hair loss.

miltefosine

Original Indication
cancer.
New Indication
leishmaniasis.

Milnacipran

Original Indication
Depression.
New Indication
Fibromyalgia syndrome.

Mecamylamine

Original Indication
Moderately severe to severe essential hypertension and uncomplicated cases of malignant hypertension.
New Indication
ADHD.

Lidocaine

Original Indication
Local anaesthesia.
New Indication
Oral corticosteroid-dependent asthma.

Galantamine

Original Indication
Polio, paralysis and anaesthesia.
New Indication
Alzheimer s disease.

Finasteride

Original Indication
Benign prostatic hyperplasia.
New Indication
Hair loss.

Duloxetine

Original Indication
Depression.
New Indication
Stress urinary incontinence.

Doxycycline

Original Indication
Bacterial infection.
New Indication
Periodontitis.

Dapoxetine

Original Indication
Analgesia and depression.
New Indication
Premature ejaculation.

Chlorpromazine

Original Indication
Anti-emetic/antihistamine.
New Indication
Non-sedating tranquillizer.

Chlorhexidine

Original Indication
oral gingivitis.
New Indication
oral mucositis.

Celecoxib

Original Indication
Osteoarthritis and adult rheumatoid arthritis.
New Indication
Familial adenomatous polyposis.

Bupropion

Original Indication
Depression.
New Indication
Smoking cessation.

Buprenorphine

Original Indication
pain.
New Indication
Opiate addiction.

Adenosine

Original Indication
Conversion to sinus rhythm of paroxysmal supraventricular tachycardia, including that associated with accessory bypass tracts (Wolff-Parkinson-White Syndrome).
New Indication
For use in conjunction with BCNU in the treatment of brain tumors.

Albuterol

Original Indication
For the prevention and relief of bronchospasm in patients with reversible obstructive airway disease, and for the prevention of exercise-induced bronchospasm.
New Indication
Prevention of paralysis due to spinal cord injury.

Alefacept

Original Indication
Treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy.
New Indication
For use as prophylaxis of rejection in patients receiving allogenic solid organ transplants.

Alendronate

Original Indication
Treatment and prevention of osteoporosis in postmenopausal women; Treatment to increase bone mass in men with osteoporosis. Treatment of glucocorticoid-induced osteoporosis in men and women receiving glucocorticoids in a daily dosage equivalent to 7.5 mg or greater of prednisone and who have low bone mineral density;Treatment of Paget s disease of bone in men and women.
New Indication
Treatment of osteogenesis imperfecta in pediatric patients 4 years of age and older.

Alfentanil

Original Indication
Alfentanil Injection is indicated: as an analgesic adjunct given in incremental doses in the maintenance of anesthesia with barbiturate/nitrous oxide/oxygen; as an analgesic administered by continuous infusion with nitrous oxide/oxygen in the maintenance of general anesthesia; as a primary anesthetic agent for the induction of anesthesia in patients undergoing general surgery in which endotracheal intubation and mechanical ventilation are required; as the analgesic component for monitored anesthesia care.
New Indication
Treatment of painful HIV-associated neuropathy.

Alprostadil

Original Indication
Treatment of erectile dysfunction due to neurogenic, vasculogenic, psychogenic, or mixed etiology.
New Indication
Treatment of severe peripheral arterial occlusive disease (critical limb ischemia) in patients where other procedures, grafts or angioplasty, are not indicated.

Alteplase

Original Indication
Restoration of funciton to central venous access devices as assessed by the ability to withdraw blood.
New Indication
Treatment of intraventricular hemmorage associated with intracerebral hemmorrhage.

Amiloride HCl solution for inhalation

Original Indication
As adjunctive treatment with thiazide diuretics or other kaliuretic-diuretic agents in congestive heart failure or hypertension to: help restore normal serum potassium levels in patients who develop hypokalemia on the kaliuretic diuretic; prevent development of hypokalemia in patients who would be exposed to particular risk if hypokalemia were to develop, e.g, digitalized patients or patients with significant cardiac arrhythmias.
New Indication
Treatment of cystic fibrosis.

Aminocaproic acid

Original Indication
Useful in enhancing hemostasis when fibrinolysis contributes to bleeding.
New Indication
For the topical treatment of traumatic hyphema of the eye.

Aminolevulinic acid hydrochloride

Original Indication
The LEVULAN KERASTICK for Topical Solution, a porphyrin precursor, plus blue light illumination using the BLU-U Blue Light Photodynamic Therapy Illuminator is indicated for the treatment of minimally to moderately thick actinic keratoses of the face or scalp.
New Indication
Treatment of esophageal dysplasia.

Apomorphine

Original Indication
For the acute, intermittent treatment of hypomobility, off episodes ( end-of-dose wearing off and unpredictable on/off episodes) associated with advanced Parkinson s disease.
New Indication
For the treatment of patients in a vegetative state or minimally conscious state for up to 12 months following a severe traumatic brain injury (traumatic or spontaneous).

Arcitumomab

Original Indication
Useful for the detection of presence, location, and extent of recurrent and metastatic colorectal adenocarcinoma involving the liver, extrahepatic abdomen, and pelvis.
New Indication
Diagnosis and localization of primary, residual, recurrent and metastatic medullary thyroid carcinoma.

Aripiprazole

Original Indication
A. as oral formulations for the: 1.Treatment of schizophrenia (Adults & Adolescents [ages 13-17]); 2. Acute treatment of manic or mixed episodes associated with bipolar I disorder as monotherapy and as an adjunct to lithium or valproate (Adults & Pediatric Patients [ages 10-17]), Maintenance treatment of bipolar I disorder (Adults); 3. Adjunctive treatment of major depressive disorder (Adults); 4.Treatment of irritability associated with autistic disorder (Pediatric Patients [ages 6-17 years]). B. as an injection for the: Acute treatment of agitation associated with schizophrenia or bipolar I disorder (Adults).
New Indication
Treatment of Tourette's syndrome.

Ascorbic acid

Original Indication
A vitamin. An ingredient of approved multi-vitamins.
New Indication
Treatment of scurvy.

Atomoxetine hydrochloride

Original Indication
Treatment of Attention Deficit Hyperactivity Disorder.
New Indication
Treatment of Tourette's Syndrome.

Bacitracin

Original Indication
The use of intramuscular bacitracin should be limited to the treatment of infants with pneumonia and empyema caused by staphylococci shown to be susceptible to the drug.
New Indication
Treatment of antibiotic-associated pseudomembranous enterocolitis caused by toxins A and B elaborated by Clostridium difficile.

Beclomethasone 17,21-diproprionate

Original Indication
Relief of the symptoms of seasonal or perennial rhinitis in those cases poorly responsive to conventional treatment. It is also indicated for the prevention of recurrence of nasal polyps following surgical removal.
New Indication
For oral administration in the treatment of intestinal graft-versus-host disease.

Bethanidine sulfate

Original Indication
Treatment of hypertension.
New Indication
Treatment of primary ventricular fibrillation.

Bivalirudin

Original Indication
Use as an anticoagulant in patients with unstable angina undergoing percutaneous transluminal coronary angioplasty.
New Indication
For use as an anticoagulant in patients with or at risk of heparin-induced thrombocytopenia/heparin-induced thrombocytopenia thrombosis syndrome.

Brimonidine

Original Indication
Indicated for the lowering of intraocular pressure in patients with open-angle glaucoma or ocular hypertension.
New Indication
Treatment of anterior ischemic optic neuropathy.

Bupivacaine

Original Indication
Indicated for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures.
New Indication
Relief of persistent pain asociated with postherpetic neuralgia.

Calcium carbonate

Original Indication
Antacid.
New Indication
Treatment of hyperphosphatemia in patients with end stage renal disease.

Chlorhexidine gluconate mouthrinse

Original Indication
For use between dental visits as part of a professional program for the treatment of gingivitis as characterized by redness and swelling of the gingivae, including gingival bleeding upon probing.
New Indication
For use in the amelioration of oral mucositis associated with cytoreductive therapy used in conditioning patients for bone marrow transplantation therapy.

Clindamycin

Original Indication
Treatment of serious infections caused by susceptible anaerobic bacteria, as well as streptococci, pneumococci and staphlococci. See details at: http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=15339#nlm34067-9.
New Indication
Treatment of Pneumocystis carinii pneumonia associated with AIDS patients.

Clonazepam

Original Indication
1. Seizure Disorders: Useful alone or as an adjunct in the treatment of the Lennox-Gastaut syndrome (petit mal variant), akinetic and myoclonic seizures. It may be useful in patients with absence seizures (petit mal) who have failed to respond to succinimides. 2. Panic Disorder: Treatment of panic disorder, with or without agoraphobia, as defined in DSM-IV.
New Indication
Treatment of hyperekplexia (startle disease).

L-cysteine

Original Indication
Cysteine Hydrochloride Injection, USP 0.5 gram is indicated for use only after dilution as an additive to Aminosyn (a crystalline amino acid solution) to meet the intravenous amino acid nutritional requirements of infants receiving total parenteral nutrition.
New Indication
For the prevention and lessening of photosensitivity in erythropoietic protoporphyria.

Dapsone

Original Indication
To control the dermatologic symptoms of Dermatitis herpetiformis. Dapsone is used alone or in combination with other anti-leprosy drugs for leprosy.
New Indication
Prophylaxis of toxoplasmosis in severely immunocompromised patients with CD4 counts below 100.

Difluprednate

Original Indication
Difluprednate ophthalmic emulsion 0.05%, a topical corticosteroid, is indicated for the treatment of inflammation and pain associated with ocular surgery.
New Indication
Treatment of endogenous and traumatic anterior uveitis and panuveitis.

Dexamethasone phosphate

Original Indication
DEXAMETHASONE SODIUM PHOSPHATE solution/ drop is indicated for the treatment of the following conditions: 1. Ophthalmic - Steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, selected infective conjunctivitides when the inherent hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation; corneal injury from chemical, radiation, or thermal bums, or penetration of foreign bodies. 2. Otic - Steroid responsive inflammatory conditions of the external auditory meatus, such as allergic otitis externa, selected purulent and nonpurulent infective otitis externa when the hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation.
New Indication
Treatment of corneal graft rejection.

Dextran 1

Original Indication
Dextran 1 is used to prevent severe anaphylactic reactions to infusions of dextran.
New Indication
Treatment of cystic fibrosis.

Dextran 70

Original Indication
Dextran 70 is a plasma volume expander used in the management of hypovolaemic shock.
New Indication
Treatment of recurrent corneal erosion unresponsive to conventional therapy.

Digitoxin

Original Indication
Digitoxin is a cardiac glycoside with positive inotropic activity. It has actions similar to those of digoxin and is used in the management of some cardiac arrhythmias and in heart failure.
New Indication
Treatment of ovarian cancer.

Dimethyl sulfoxide

Original Indication
Symptomatic relief of patients with interstitial cystitis.
New Indication
Treatment of cutaneous manifestations of scleroderma.

Doripenem

Original Indication
Treatment of the following infections caused by designated susceptible bacteria: Complicated intra-abdominal infections; Complicated urinary tract infections, including pyelonephritis. See details at: http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=8708#nlm34067-9.
New Indication
Treatment of bronchopulmonary infection in patients with cystic fibrosis who are colonized with Pseudomonas aeruginosa or Burkholderia cepacia.

Ethinyl Estradiol

Original Indication
A synthetic oestrogen with actions similar to those of estradiol. It is frequently used as the oestrogenic component of combined oral contraceptive preparations.
New Indication
Treatment of Turner's syndrome.

Floxuridine

Original Indication
Effective in the palliative management of gastrointestinal adenocarcinoma metastatic to the liver, when given by continuous regional intra-arterial infusion in carefully selected patients who are considered incurable by surgery or other means.
New Indication
Intraperitoneal treatment of gastric cancer.

Fluorouracil

Original Indication
Effective in the palliative management of carcinoma of the colon, rectum, breast, stomach and pancreas.
New Indication
For use in combination with interferon alpha-2a, recombinant, for the treatment of esophageal carcinoma.

Fluoxetine

Original Indication
Treatment of Major Depressive Disorder, Obsessive Compulsive Disorder, Bulimia Nervosa, Panic Disorder.
New Indication
Treatment of body dysmorphic disorder in children and adolescents.

Gabapentin

Original Indication
Indicated for the management of postherpetic neuralgia in adults. It is also indicated as adjunctive therapy in the treatment of partial seizures with and without secondary generalization in patients over 12 years of age with epilepsy. As adjunctive therapy in the treatment of partial seizures in pediatric patients age 3 12 years.
New Indication
Treatment of amyotrophic lateral sclerosis.

Glatiramer acetate for injection

Original Indication
For reduction of the frequency of relapses in patients with relapsing-remitting multiple sclerosis.
New Indication
Treatment of amyothrophic lateral sclerosis (ALS).

Glycopyrrolate

Original Indication
Glycopyrrolate injection is indicated, 1. for use as a preoperative antimuscarinic to reduce salivary, tracheobronchial, and pharyngeal secretions; to reduce the volume and free acidity of gastric secretions; and, to block cardiac vagal inhibitory reflexes during induction of anesthesia and intubation. 2. For use in adults as adjunctive therapy for the treatment of peptic ulcer when rapid anticholinergic effect is desired or when oral medication is not tolerated.
New Indication
Treatment of pathologic (chronic moderate to severe) drooling in pediatric patients.

Guanethidine monosulfate

Original Indication
Treatment of moderate and severe hypertension, either alone or as an adjunct, and for the treatment of renal hypertension, including that secondary to pyelonephritis, renal amyloidosis, and renal artery stenosis.
New Indication
Treatment of moderate to severe reflex sympathetic dystrophy and causalgia.

Guanfacine

Original Indication
Guanfacine tablet, extended release is indicated for the treatment of Attention Deficit Hyperactivity Disorder.
New Indication
Treatment of fragile X syndrome.

Heparin

Original Indication
Heparin Sodium Injection is indicated for:1. Anticoagulant therapy in prophylaxis and treatment of venous thrombosis and its extension;2.Low-dose regimen for prevention of postoperative deep venous thrombosis and pulmonary embolism in patients undergoing major abdominothoracic surgery or who, for other reasons, are at risk of developing thromboembolic disease; 3. Prophylaxis and treatment of pulmonary embolism; 4. Atrial fibrillation with embolization; 5. Diagnosis and treatment of acute and chronic consumptive coagulopathies (disseminated intravascular coagulation); 6. Prevention of clotting in arterial and cardiac surgery; 7. Prophylaxis and treatment of peripheral arterial embolism. 8. Heparin may also be employed as an anticoagulant in blood transfusions, extracorporeal circulation, and dialysis procedures and in blood samples for laboratory purposes.
New Indication
Treatment of cystic fibrosis.

Histamine

Original Indication
Positive Skin Test Control - Histamine is indicated as an adjunct in allergy skin test for diagnosis, as a positive control to test wheal-flare response of skin for evaluation of skin test response to allergenic extracts.
New Indication
For use as an adjunct to cytokine therapy in the treatment of malignant melanoma.

Protein C concentrate

Original Indication
Ceprotin is indicated for patients with severe congenital Protein C deficiency for the prevention and treatment of venous thrombosis and purpura fulminans.
New Indication
For replacement therapy in patients with congenital or acquired protein C deficiency for the prevention and treatment of warfarin-induced skin necrosis during oral anticoagulation.

Procarbazine hydrochloride

Original Indication
Matulane is indicated for use in combination with other anticancer drugs for the treatment of Stage III and IV Hodgkin's disease. Matulane is used as part of the MOPP (nitrogen mustard, vincristine, procarbazine, prednisone) regimen.
New Indication
Treatment of malignant glioma.

Quinine sulfate

Original Indication
Treatment of uncomplicated Plasmodium falciparum malaria.
New Indication
Treatment of malaria excluding Plasmodium faliparum.

Rapamycin (mTOR) inhibitor

Original Indication
Sirolimus is an immunosuppressive agent indicated for the prophylaxis of organ rejection in patients aged 13 years receiving renal transplants.
New Indication
Treatment of tuberous sclerosis complex.

Recombinant human C1 inhibitor

Original Indication
Berinert is a plasma-derived C1 Esterase Inhibitor (Human) indicated for the treatment of acute abdominal or facial attacks of hereditary angioedema in adult and adolescent patients.
New Indication
Prevention and/or treatment of delayed graft function after solid organ transplantation.

Repository corticotropin or adrenocorticotropic hormone

Original Indication
Corticotropin is indicated for treatment of acute exacerbations of multiple sclerosis.
New Indication
Treatment of infantile spasms.

Rifabutin

Original Indication
Prevention of disseminated Mycobacterium avium complex disease in patients with advanced HIV infections.
New Indication
Treatment of disseminated Mycobacterium avium complex disease.

Riluzole

Original Indication
Treatment of patients with amyotrophic lateral sclerosis.
New Indication
Treatment of Huntington's disease.

Sermorelin acetate

Original Indication
Treatment of idiopathic or organic growth hormone deficiency in children with growth failure.
New Indication
Adjunct to gonadotropin therapy in the induction of ovulation in women with anovulatory or oligo-ovulatory infertility who fail to ovulate in response to adequate treatment with clomiphene citrate alone and gonadotropin therapy alone.

Sodium phenylbutyrate

Original Indication
Adjunctive therapy in the chronic managment of patients with urea cycle disorders involving deficiencies of carbamylphosphate synthetase, ornithine transcarbamylase, or argininosuccinic acid synthetase.
New Indication
Treatment for sickling disorders, which include S-S hemoglobinopathy, S-C hemoglobinopathy, and S-thalassemia hemoglobinopathy.

Sodium thiosulfate

Original Indication
Used in the treatment of cyanide poisoning. Sodium thiosulfate may be used in the management of extravasation of chlormethine and some other antineoplastics. It is also used to inactivate some antineoplastics before disposal. Sodium thiosulfate, given by intravenous infusion, has also been investigated for reducing the systemic toxicity of some antineoplastics. It has been reported to reduce the incidence of nephrotoxicity associated with intraperitoneal cisplatin.
New Indication
Prevention of platinum-induced ototoxicity in pediatric patients.

Somatropin

Original Indication
For long-term treatment of children who have growth failure due to a lack of adequate endogenous growth hormone secretion.
New Indication
Adjunct for the induction of ovulation in women with infertility due to hypogonadotropic hypogonadism or bilateral tubal occlusion or unexplained infertility, who are undergoing in vivo or in vitro fertilization procedures.

Succimer

Original Indication
Treatment of lead poisoning in children pediatric patients with blood lead levels above 45 g/dL.
New Indication
Prevention of cystine kidney stone formation in patients with homozygous cystinuria who are prone to stone development.

Methoxsalen

Original Indication
A. Photochemotherapy (methoxsalen with long wave UVA radiation) is indicated for the symptomatic control of severe, recalcitrant, disabling psoriasis not adequately responsive to other forms of therapy and when the diagnosis has been supported by biopsy. B. Photochemotherapy (methoxsalen with long wave ultraviolet radiation) is indicated for the repigmentation of idiopathic vitiligo.C. Photopheresis (methoxsalen with long wave ultraviolet radiation of white blood cells) is indicated for use with the UVAR* System in the palliative treatment of the skin manifestations of cutaneous T-cell lymphoma in persons who have not been responsive to other forms of treatment.
New Indication
For use in conjunction with the UVAR photopheresis system to treat graft versus host disease.

Metyrosine

Original Indication
Treatment of patients with pheochromocytoma for:1. Preoperative preparation of patients for surgery; 2. Management of patients when surgery is contraindicated; 3. Chronic treatment of patients with malignant pheochromocytoma.
New Indication
Treatment of velocardiofacial syndrome associated psychosis.

Microbubble contrast agent

Original Indication
Activated DEFINITY (Perflutren Lipid Microsphere) Injectable Suspension is indicated for use in patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border.
New Indication
Intraoperative aid in the identification and localization of intracranial tumors.

Midazolam HCl

Original Indication
1. Intramuscularly or intravenously for preoperative sedation/anxiolysis/amnesia; 2. Intravenously as an agent for sedation/anxiolysis/amnesia prior to or during diagnostic, therapeutic or endoscopic procedures, such as bronchoscopy, gastroscopy, cystoscopy, coronary angiography, cardiac catheterization, oncology procedures, radiologic procedures, suture of lacerations and other procedures either alone or in combination with other CNS depressants; 3. Intravenously for induction of general anesthesia, before administration of other anesthetic agents. 4. Continuous intravenous infusion for sedation of intubated and mechanically ventilated patients as a component of anesthesia or during treatment in a critical care setting.
New Indication
Treatment of bouts of increased seizure activity in selected refractory patients with epilepsy who are on stable regimens of anti-epileptic drugs and who require intermittent use of midazolam.

Midazolam nasal spray

Original Indication
Midazolam hydrochloride syrup is indicated for use in pediatric patients for sedation, anxiolysis and amnesia prior to diagnostic, therapeutic or endoscopic procedures or before induction of anesthesia.
New Indication
Rescue treatment of seizures in patients who require control of intermittent bouts of increased seizure activity (e.g. acute repetitive seizures, seizure clusters).

Mifepristone

Original Indication
Medical termination of intrauterine pregnancy through 49 days pregnancy.
New Indication
Treatment of Cushing's syndrome secondary to ectopic ACTH secretion.

Minocycline HCL

Original Indication
Treatment of the infections due to susceptible strains of the designated microorganisms: see detailed list in http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=4676#nlm34067-9.
New Indication
Treatment of chronic malignant pleural effusion.

Misoprostol

Original Indication
Reducing the risk of NSAID induced gastric ulcers in patients at high risk of complications from gastric ulcer, e.g, the elderly and patients with concomitant debilitating disease, as well as patients at high risk of developing gastric ulceration, such as patients with a history of ulcer.
New Indication
Treatment of intrauterine fetal death not accompanied by complete expulsion of the products of conception in the second and third trimesters of pregnancy.

Nabumetone

Original Indication
It is indicated for relief of signs and symptoms of osteoarthritis and rheumatoid arthritis.
New Indication
Treatment of pediatric juvenile rheumatoid arthritis.

Nevirapine

Original Indication
Use in combination with other antiretroviral agents for the treatment of HIV-1 infection.
New Indication
Prevention of HIV infection in pediatric patients under the age of 16 years.

Nitroprusside

Original Indication
1. The immediate reduction of blood pressure of patients in hypertensive crises. 2. Producing controlled hypotension in order to reduce bleeding during surgery. 3. The treatment of acute congestive heart failure.
New Indication
Treatment and prevention of cerebral vasospasm following subarachnoid hemorrhage.

Omega-3 (n-3) polyunsaturated fatty acids

Original Indication
Omega-3-acid ethyl ester is indicated as an adjunct to diet to reduce very high ( 500 mg/dL) triglyceride levels in adult patients.
New Indication
Treatment of IgA nephropathy.

Oxaliplatin

Original Indication
Used in combination with infusional 5-FU/LV, it is indicated for: 1. adjuvant treatment of stage III colon cancer in patients who have undergone complete resection of the primary tumor. 2. treatment of advanced colorectal cancer.
New Indication
Treatment of ovarian cancer.

Oxandrolone

Original Indication
As adjunctive therapy to promote weight gain after weight loss following extensive surgery, chronic infections, or severe trauma, and in some patients who without definite pathophysiologic reasons fail to gain or to maintain normal weight, to offset the protein catabolism associated with prolonged administration of corticosteroids, and for the relief of the bone pain frequently accompanying osteoporosis.
New Indication
Treatment of short stature associated with Turner's syndrome.

Pazopanib

Original Indication
Treatment of patients with advanced renal cell carcinoma.
New Indication
Treatment of soft tissue sarcomas.

Peginterferon alfa-2a

Original Indication
Alone or in combination with COPEGUS, it is indicated for the treatment of adults with chronic hepatitis C virus infection who have compensated liver disease and have not been previously treated with interferon alpha. It's also indicated for the treatment of adult patients with HBeAg positive and HBeAg negative chronic hepatitis B who have compensated liver disease and evidence of viral replication and liver inflammation.
New Indication
Treatment of chronic myelogenous leukemia.

Peginterferon alfa-2b

Original Indication
1. Combination therapy with REBETOL (ribavirin): Chronic Hepatitis C (CHC) in patients 3 years with compensated liver disease. 2. Monotherapy: CHC in patients ( 18 years) with compensated liver disease previously untreated with interferon alpha.
New Indication
Treatment of malignant melanoma stages IIb through IV.

Pentosan polysulfate sodium

Original Indication
Relief of bladder pain or discomfort associated with interstitial cystitis.
New Indication
Treatment of sickle cell disease.

Polyphenon E

Original Indication
Veregen is a topical ointment indicated for the treatment of external genital and perianal warts (Condylomata acuminata) in immunocompetent patients 18 years and older.
New Indication
Treatment of chronic lymphocytic leukemia.

Pramipexole

Original Indication
1. the treatment of the signs and symptoms of idiopathic Parkinson's disease. 2. the treatment of moderate-to-severe primary Restless Legs Syndrome.
New Indication
Treatment of Tourette's syndrome in pediatric patients.

Praziquantel

Original Indication
Treatment of infections due to: all species of schistosoma (e.g. Schistosoma mekongi, Schistosoma japonicum, Schistosoma mansoni and Schistosoma hematobium), and infections due to the liver flukes, Clonorchis sinensis/ Opisthorchis viverrini (approval of this indication was based on studies in which the two species were not differentiated).
New Indication
Treatment of neurocysticercosis.

Progesterone

Original Indication
Prometrium (progesterone) capsule is indicated for use in the prevention of endometrial hyperplasia in nonhysterectomized postmenopausal women who are receiving conjugated estrogens tablets. They are also indicated for use in secondary amenorrhea.
New Indication
Establishment and maintenance of pregnancy in women undergoing in vitro fertilization or embryo transfer procedures.

Medroxyprogesterone acetate

Original Indication
Treatment of secondary amenorrhea and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as fibroids or uterine cancer. It is also indicated to reduce the incidence of endometrial hyperplasia in nonhysterectomized postmenopausal women receiving daily oral conjugated estrogens 0.625 mg tablets.
New Indication
Treatment of immune thrombocytopenic purpura.

Propranolol

Original Indication
1. Management of hypertension. 2. Decrease angina frequency and increase exercise tolerance in patients with angina pectoris. 3. Control ventricular rate in patients with atrial fibrillation and a rapid ventricular response. 4. Reduce cardiovascular mortality in patients who have survived the acute phase of myocardial infarction and are clinically stable. 5. Prophylaxis of common migraine headache. 6. Management of familial or hereditary essential tremor. 7. Improves NYHA functional class in symptomatic patients with hypertrophic subaortic stenosis. 8. As an adjunct to alpha-adrenergic blockade to control blood pressure and reduce symptoms of catecholamine-secreting tumors.
New Indication
Treatment of proliferating infantile hemangiomas requiring systemic therapy.

Protirelin

Original Indication
1. As an adjunctive agent in the diagnostic assessment of thyroid function. 2. As an adjunct to evaluate the effectiveness of thyrotropin suppression with a particular dose of T4 in patients with nodular or diffuse goiter. 3. Adjunctively, for adjustment of thyroid hormone dosage given to patients with primary hypothyroidism.
New Indication
Prevention of infant respiratory distress syndrome associated with prematurity.

Rabbit anti-human thymocyte globulin (rATG)

Original Indication
Treatment of renal transplant acute rejection in conjunction with concomitant immunosuppression.
New Indication
Treatment of myelodysplastic syndrome.

Risedronate sodium

Original Indication
1.Treatment and prevention of postmenopausal osteoporosis; 2.Treatment to increase bone mass in men with osteoporosis; 3.Treatment and prevention of glucocorticoid-induced osteoporosis; 4.Treatment of Paget s disease.
New Indication
Treatment of patients with osteogenesis imperfecta.

Sucralfate

Original Indication
1. Short-term treatment (up to 8 weeks) of active duodenal ulcer. 2. Maintenance therapy for duodenal ulcer patients at reduced dosage after healing ofacute ulcers.
New Indication
Treatment of oral mucositis and stomatitis following radiation therapy for head and neck cancer.

Tenofovir disoproxil fumarate

Original Indication
It is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and adolescents. It is indicated for the treatment of chronic hepatitis B in adults.
New Indication
Treatment of pediatric HIV infection.

Testosterone propionate ointment 2%

Original Indication
Testosterone gel is an androgen indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone: Primary Hypogonadism (Congenital or Acquired) - testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter's syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. Hypogonadotropic Hypogonadism (Congenital or Acquired) - idiopathic gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation.
New Indication
Treatment of vulvar dystrophies.

Tiotropium bromide

Original Indication
Tiotropium bromide inhalation powder is indicated for the long-term, once-daily, maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. It is also indicated to reduce exacerbations in COPD patients.
New Indication
To improve pulmonary function in conjunction with standard therapy in the management of patients with cystic fibrosis.

Toremifene

Original Indication
Treatment of metastatic breast cancer in postmenopausal women with estrogen positive or receptor unknown tumors.
New Indication
Treatment of desmoid tumors.

Tramadol hydrochloride

Original Indication
Management of moderate to moderately severe pain in adults.
New Indication
Management of postherpetic neuralgia.

Trastuzumab

Original Indication
As a single agent it is indicated for the treatment of patients with metastatic breast cancer whose tumors overexpress the HER2 protein and who have received one or more chemotherapy regimens for their metastatic disease. In combination with paclitaxel, it is indicated for treatment of patients with metastatic breast cancer whose tumors overexpress the HER2 protein and who have not received chemotherapy for their metastatic disease.
New Indication
Treatment of patients with pancreatic cancer that overexpress p185HER2.

Triptorelin pamoate

Original Indication
Palliative treatment of advanced prostate cancer.
New Indication
For use in the palliative treatment of advanced ovarian carcinoma of epithelial origin.

Valproic acid, sodium

Original Indication
Divalproex sodium extended-release is indicated for the treatment of acute manic or mixed episodes associated with bipolar disorder, with or without psychotic features. It is indicated for prophylaxis of migraine headaches in adults. It is indicated as monotherapy and adjunctive therapy in the treatment of adults and children 10 years of age or older with complex partial seizures that occur either in isolation or in association with other types of seizures. It is also indicated for use as sole and adjunctive therapy in the treatment of simple and complex absence seizures in adults and children 10 years of age or older, and adjunctively in adults and children 10 years of age or older with multiple seizure types that include absence seizures.
New Indication
Treatment of familial adenomatous polyposis.

111Indium pentetreotide

Original Indication
Indium In-111 pentetreotide is an agent for the scintigraphic localization of primary and metastatic neuroendocrine tumors bearing somatostatin receptors.
New Indication
Treatment of somatostatin receptor positive neuroendocrine tumors.

Alglucerase injection

Original Indication
Use as a long-term enzyme replacement therapy for children, adolescents and adult patients with a confirmed diagnosis of Type I Gaucher disease who exhibit signs and symptoms that are severe enough to result in one or more of the following conditions: a. moderate-to-severe anemia; b. thrombocytopenia with bleeding tendency; c. bone disease; d.significant hepatomegaly or splenomegaly.
New Indication
Replacement therapy in patients with Type II and III Gaucher's disease.

Alitretinoin

Original Indication
Topical treatment of cutaneous lesions in patients with AIDS-related Kaposi's sarcoma.
New Indication
Treatment of acute promyelocytic leukemia.

Alpha1-Proteinase Inhibitor (Human)

Original Indication
For chronic replacement therapy of individuals having congenital deficiency of alpha1- proteinase inhibitor with clinically demonstrable panacinar emphysema.
New Indication
Treatment of cystic fibrosis.

Ambrisentan

Original Indication
Treatment of pulmonary arterial hypertension (WHO group I) in patients with WHO class II or III symptoms to improve exercise capacity and delay clinical worsening.
New Indication
Treatment of idiopathic pulmonary fibrosis.

4-aminosalicylic acid

Original Indication
Treatment of tuberculosis.
New Indication
Treatment of mild to moderate ulcerative colitis in patients intolerant to sulfasalazine.

Amifostine

Original Indication
To reduce the cumulative renal toxicity associated with repeated administration of cisplatin in patients with advanced ovarian cancer.
New Indication
For use as a chemoprotective agent for cyclophosphamide in the treatment of advanced ovarian carcinoma.

Anagrelide

Original Indication
Treatment of patients with essential thrombocythemia to reduce the elevated platelet count and the risk of thrombosis and to ameliorate associated symptoms.
New Indication
Treatment of polycythemia vera.

Anti-tac (human)

Original Indication
Prophylaxis of acute organ rejection in patients receiving renal transplants, to be used as a part of an immunosuppressive regimen that includes cyclosporine and corticosteroids.
New Indication
Prevention of acute graft-vs-host disease following bone marrow transplantation.

Arsenic trioxide

Original Indication
For induction of remission and consolidation in patients with acute promyelocytic leukemia (APL) who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression.
New Indication
Treatment of multiple myeloma.

Atovaquone

Original Indication
For the acute oral treatment of mild to moderate Pneumocystis carinii pneumonia in patients who are intolerant to trimethoprim-sulfamethoxazole.
New Indication
Treatment and suppression of Toxoplasma gondii encephalitis.

Azacitidine

Original Indication
Treatment of patients with the following myelodysplastic syndrome subtypes: refractory anemia or refractory anemia with ringed sideroblasts (if accompanied by neutropenia or thrombocytopenia and requiring transfusions), refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia.
New Indication
Treatment of acute myeloid leukemia.

Beractant (Bovine surfactant extract)

Original Indication
Treatment of ("rescue") of premature infants with Respiratory Distress Syndrome confirmed by x-ray and requiring mechanical ventilation.
New Indication
Treatment of full-term newborn infants with respiratory failure caused by meconium aspiration syndrome, persistent pulmonary hypertension of the newborn, or pneumonia and sepsis.

Bosentan

Original Indication
Treatment of pulmonary arterial hypertension (WHO Group I) in patients with WHO Class II - IV symptoms, to improve exercise ability and decrease the rate of clinical worsening .
New Indication
Treatment of idiopathic pulmonary fibrosis.

Busulfan

Original Indication
Busulfan injection is indicated for use in combination with cyclophosphamide as a conditioning regimen prior to allogeneic hematopoietic progenitor cell transplantation for chronic myelogenous leukemia.
New Indication
Treatment of primary brain malignancies.

Calfactant

Original Indication
Treatment and prevention of respiratory failure due to pulmonary surfactant deficiency in preterm infants.
New Indication
Acute respiratory distress syndrome.

Canakinumab

Original Indication
Treatment of cryopyrin-associated periodic syndromes, in adults and children 4 years of age and older including: Familial Cold Autoinflammatory Syndrome and Muckle-Wells Syndrome.
New Indication
Treatment of systemic onset juvenile idiopathic arthritis.

Capsaicin

Original Indication
Management of neuropathic pain associated with postherpetic neuralgia.
New Indication
Treatment of erythromelalgia.

Cladribine

Original Indication
Treatment of hairy cell leukemia.
New Indication
Treatment of chronic lymphocytic leukemia.

Clofarabine

Original Indication
Treatment of pediatric patients 1 to 21 years old with relapsed or refractory acute lymphoblastic leukemia after at least two prior regimens.
New Indication
Treatment of acute myelogenous leukemia.

Coagulation Factor VIIa (Recombinant)

Original Indication
Treatment of bleeding episodes in hemophilia A or B patients with inhibitors to Factor VIII or Factor IX.
New Indication
Treatment of bleeding episodes in Glanzmann's thrombasthenia.

Cysteamine hydrochloride

Original Indication
Treatment of nephropathic cystinosis in adults and children.
New Indication
Treatment of corneal cystine crystal accumulation in cystinosis patients.

Cytomegalovirus immunoglobulin intravenous (human)

Original Indication
#1) Attenuation of primary CMV disease associated with kidney transplant recipients who are seronegative for CMV and who receive a kidney from a CMV seropositve donor; #2) Prophylaxis of CMV disease associated transplantation of kidney (all other), lung,.
New Indication
For use in conjunction with ganciclovir sodium for the treatment of cytomegalovirus pneumonia in bone marrow transplant patients.

Daunorubicin liposomal

Original Indication
Daunorubicin hydrochloride in combination with other approved anticancer drugs is indicated for remission induction in acute nonlymphocytic leukemia (myelogenous, monocytic, erythroid) of adults and for remission induction in acute lymphocytic leukemia of children and adults.
New Indication
Treatment of acute myeloid leukemia.

Decitabine

Original Indication
For treatment of patients with myelodysplastic syndromes (MDS) including previously treated and untreated, de novo and secondary MDS of all French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia.
New Indication
Treatment of chronic myelogenous leukemia.

Eculizumab

Original Indication
Treatment of paroxysmal nocturnal hemoglobinuria to reduce hemolysis.
New Indication
Treatment of dermatomyositis.

Epoprostenol

Original Indication
Long-term intravenous treatment of primary pulmonary hypertension and pulmonary hypertension associated with the scleroderma spectrum of disease in NYHA Class III and Class IV patients who do not respond adequately to conventional therapy.
New Indication
Replacement of heparin in patients requiring hemodialysis and who are at increased risk of hemorrhage.

Filgrastim

Original Indication
Decreasing the incidence of infection as manifested by febrile neutropenia in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever.
New Indication
Treatment of myelodysplastic syndrome.

Fludarabine phosphate

Original Indication
Fludara (Fludarabine Phosphate Injection) is indicated for the treatment of patients with B-cell chronic lymphocytic leukemia (CLL) who have not responded to or whose disease has progressed during treatment with at least one standard alkylating-agent containing regimen.
New Indication
Treatment and management of patients with non-Hodgkins lymphoma.

Heme arginate

Original Indication
Amelioration of recurrent attacks of acute intermittent porphyria temporally related to the menstrual cycle in susceptible women.
New Indication
Treatment of myelodysplastic syndromes.

Idarubicin

Original Indication
Treatment of acute myelogenous leukemia, also referred to as acute nonlymphocytic leukemia.
New Indication
Treatment of acute lymphoblastic leukemia in pediatric patients.

Ifosfamide

Original Indication
In combination with certain other approved antineoplastic agents, for third line chemotherapy in the treatment of germ cell testicular cancer.
New Indication
Treatment of bone sarcomas.

Iloprost solution for infusion

Original Indication
Treatment of pulmonary arterial hypertension (WHO Group I) in patients with NYHA Class III or IV symptoms.
New Indication
Treatment of Raynaud's phenomenon secondary to systemic sclerosis.

Interferon gamma-1b

Original Indication
Actimmune is indicated for delaying time to disease progression in patients with severe, malignant osteopetrosis.
New Indication
Treatment of idiopathic pulmonary fibrosis.

Lenalidomide

Original Indication
For use in combination with dexamethasone for the treatment of multiple myeloma patients who have received at least one prior therapy.
New Indication
Treatment of chronic lymphocytic leukemia.

Levocarnitine

Original Indication
1. Treatment of primary systemic carnitine deficiency. 2. Acute and chronic treatment of patients with an inborn error of metabolism which results in a secondary carnitine deficiency.
New Indication
For the prevention of secondary carnitine deficiency in valproic acid toxicity.

Mecasermin

Original Indication
Long-term treatment of growth failure in children with severe primary insulin growth factor-1 deficiency or with growth hormone gene deletion who have developed neutralizing antibodies to growth hormone.
New Indication
Treatment of amyotrophic lateral sclerosis.

Mecasermin rinfabate

Original Indication
Treatment of growth failure in children with severe primary insulin-like growth factor-1 deficiency or with growth hormone gene deletion who have developed neutralizing antibodies to growth hormone.
New Indication
Treatment of major burns that require hospitalization.

Melphalan

Original Indication
Melphalan Hydrochloride for Injection is indicated for the palliative treatment of patients with multiple myeloma for whom oral melphalan is not appropriate.
New Indication
For use in hyperthermic regional limb perfusion to treat metastatic melanoma of the extremity.

Mesna

Original Indication
For use as a prophylactic agent in reducing the incidence of ifosfamide-induced hemorrhagic cystitis.
New Indication
Inhibition of the urotoxic effects induced by oxazaphosphorine compounds such as cyclophosphamide.

Miglustat

Original Indication
Treatment of mild to moderate Type I Gaucher disease in adults for whom enzyme replacement therapy is not a therapeutic option (e.g, due to constraints such as allergy, hypersensitivity, or poor venous access).
New Indication
Treatment of the neurological manifestations of Niemann-Pick disease,type C.

Mitomycin-C

Original Indication
Mitomycin has been shown to be useful in the therapy of disseminated adenocarcinoma of the stomach or pancreas in proven combinations with other approved chemotherapeutic agents and as palliative treatment when other modalities have failed.
New Indication
Treatment of refractory glaucoma as an adjunct to ab externo glaucoma surgery.

Mycophenolate mofetil

Original Indication
Mycophenolate mofetil is indicated for the prophylaxis of organ rejection in patients receiving allogeneic renal, cardiac or hepatic transplants. CellCept should be used concomitantly with cyclosporine and corticosteroids.
New Indication
Treatment of pemphigus vulgaris.

Nilotinib

Original Indication
For the treatment of chronic phase and accelerated phase Philadelphia chromosome positive chronic myelogenous leukemia in adult patients resistant to or intolerant to prior therapy that included imatinib.
New Indication
Treatment of gastrointestinal stromal tumors.

Nitazoxanide

Original Indication
Treatment of diarrhea caused by Cryptosporidium parvum and Giardia lamblia.
New Indication
Treatment for intestinal amebiasis.

Nitisinone

Original Indication
Adjunctive therapy to dietary restriction of tyrosine and phenylalanine in the treatment of hereditary tyrosinemia type 1.
New Indication
Treatment of alkaptonuria.

Nitric oxide

Original Indication
In conjunction with ventilatory support and other appropriate agents, in the treatment of term and near-term (>34 weeks) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension, where it improves oxygenation and reduces the need for extracorporeal membrane oxygenation.
New Indication
Treatment of acute respiratory distress syndrome in adults.

Pentostatin

Original Indication
Single agent treatment for adult patients with alpha-interferon-refractory hairy cell leukemia with active disease as defined by clinically significant anemia, neutropenia, thrombocytopenia, or disease-related symptoms.
New Indication
Treatment of patients with chronic lymphocytic leukemia.

Porfimer sodium

Original Indication
1. Palliation of patients with completely obstructing esophageal cancer, or of patients with partially obstructing esophageal cancer who, in the opinion of their physician, cannot be satisfactorily treated with Nd:YAG laser therapy. 2. Reduction of obstruction and palliation of symptoms in patients with completely or partially obstructing endobronchial non-small-cell lung cancer (NSCLC). 3. Treatment of microinvasive endobronchial NSCLC in patients for whom surgery and radiotherapy are not indicated. 4. Ablation of high-grade dysplasia in Barrett s esophagus patients who do not undergo esophagectomy.
New Indication
For the photodynamic therapy of patients with transitional cell carcinoma in situ of the urinary bladder.

Pralatrexate

Original Indication
Treatment of patients with relapsed or refractory peripheral T-cell lymphoma.
New Indication
Treatment of diffuse large B-cell lymphoma.

Primaquine phosphate

Original Indication
For the radical cure (prevention of relapse) of vivax malaria.
New Indication
For use in combination with clindamycin hydrochloride in the treatment of Pneumocystis carinii pneumonia associated with AIDS.

Vorinostat

Original Indication
Treatment of cutaneous manifestations in patients with cutaneous T-cell lymphoma who have progressive, persistant or recurrent disease on or following two systemic therapies.
New Indication
Treatment of multiple myeloma.

N-acetylcysteine

Original Indication
Administered intravenously within 8 to 10 hours after ingestion of a potentially hepatotoxic quantity of acetaminophen, it is indicated to prevent or lessen hepatic injury .
New Indication
Treatment of acute liver failure.

Adalimumab

Original Indication
1. Rheumatoid Arthritis - Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active disease. 2. Psoriatic Arthritis - Reducing signs and symptoms of active arthritis, inhibiting the progression of structural damage, and improving physical function. 3. Ankylosing Spondylitis - Reducing signs and symptoms in patients with active disease. 4. Crohn s Disease - Reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn s disease who have had an inadequate response to conventional therapy. Reducing signs and symptoms and inducing clinical remission in these patients if they have also lost response to or are intolerant to infliximab. 5. Plaque Psoriasis - The treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phot
New Indication
Treatment of pediatric Crohn's disease.

Aldesleukin

Original Indication
Treatment of adults with metastatic melanoma.
New Indication
Treatment of primary immunodeficiency disease associated with T-cell defects.

Allopurinol

Original Indication
Management of patients with leukemia, lymphoma, and solid tumor malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels and who cannot tolerate oral therapy.
New Indication
Treatment of Chagas' disease.

Aminosidine (Paromomycin)

Original Indication
It is indicated for intestinal amebiasis acute and chronic.
New Indication
Treatment of tuberculosis.

Azathioprine

Original Indication
Azathioprine is indicated for the management of active rheumatoid arthritis to reduce signs and symptoms.
New Indication
Treatment of oral manifestations of graft-versus-host disease.

Aztreonam

Original Indication
It is indicated for the treatment of the infections caused by various susceptible gram-negative microorganisms. See http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050580s040,050632s013lbl.pdf.
New Indication
Improvement of respiratory symptoms in patients with bronchiectasis and gram-negative bacteria in the airways.

Bevacizumab

Original Indication
Glioblastoma, as a single agent for patients with progressive disease following prior therapy.
New Indication
Treatment of ovarian cancer.

Bleomycin sulfate

Original Indication
Bleomycin has been shown to be useful in the management of the following neoplasms either as a single agent or in proven combinations with other approved chemotherapeutic agents: Squamous cell carcinoma from head and neck; Lymphomas (Hodgkin's and non-Hodgkin's); Testicular Carcinoma (embryonal cell, choriocarcinoma and teratocarcinoma).
New Indication
Treatment of pancreatic cancer.

Botulinum toxin type A

Original Indication
BOTOX Cosmetic is indicated for the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients 65 years of age.
New Indication
Treatment of dynamic muscle contracture in pediatric cerebral palsy patients.

Cetuximab

Original Indication
As a single agent, EGFR-expressing metastatic colorectal cancer after failure of both irinotecan- and oxaliplatin-based regimens or in patients who are intolerant to irinotecan-based regimens.; In combination with irinotecan, EGFR-expressing metastatic colorectal carcinoma in patients who are refractory to irinotecan-based chemotherapy.
New Indication
Treatment of pancreatic cancer.

Lyposomal cisplatin

Original Indication
1. Metastatic Testicular Tumors. In established combination therapy with other approved chemotherapeutic agents in patients with metastatic testicular tumors who have already received appropriate surgical and/or radiotherapeutic procedures. 2. Advanced Bladder Cancer. It is indicated as a single agent for patients with transitional cell bladder cancer which is no longer amenable to local treatments, such as surgery and/or radiotherapy.
New Indication
Treatment of osteogenic sarcoma metastatic to the lung.

Collagenase (lyophilized) for injection

Original Indication
Collagenase Santyl Ointment is indicated for debriding chronic dermal ulcers and severely burned areas.
New Indication
Treatment of Peyronie's disease.

L-cycloserine

Original Indication
Treatment of acute urinary tract infections caused by susceptible strains of gram positive and gramcnegative bacteria, especially Enterobacter spp. and Escherichia coli.
New Indication
Treatment of Gaucher's disease.

Cyclosporine

Original Indication
Prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. It is always to be used with adrenal corticosteroids. The drug may also be used in the treatment of chronic rejection in patients previously treated with other immunosuppressive agents. .
New Indication
Treatment of acute rejection in patients requiring allogenic lung transplants.

Ribavirin

Original Indication
Ribavirin tablets in combination with peginterferon alfa-2a are indicated for the treatment of adults with chronic hepatitis C virus infection who have compensated liver disease and have not been previously treated with interferon alpha.
New Indication
Treatment of hemorrhagic fever with renal syndrome.

Rituximab

Original Indication
Treatment of patients with:1. Non-Hodgkin s Lymphoma. 2. Chronic Lymphocytic Leukemia.
New Indication
Treatment of immune thrombocytopenic purpura.

Sorafenib

Original Indication
Treatment of patients with advanced renal cell carcinoma.
New Indication
Treatment of stage IIB through stage IV melanoma.

Tranexamic acid

Original Indication
Tranexamic acid Injection is indicated in patients with hemophilia for short-term use (two to eight days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction.
New Indication
Treatment of hereditary angioneurotic edema.

Urofollitropin

Original Indication
Bravelle administered SC or IM in conjunction with hCG, is indicated for: 1.ovulation induction in patients; 2. multiple follicular development (controlled ovarian stimulation) during ART cycles, in patients who have previously received pituitary suppression.
New Indication
For the initiation and re-initiation of spermatogenesis in adult males with reproductive failure due to hypothalamic or pituitary dysfunction, hypogonadotropic hypogonadism.

Ursodiol

Original Indication
1. Ursodiol is indicated for patients with radiolucent, noncalcified gallbladder stones < 20 mm in greatest diameter in whom elective cholecystectomy would be undertaken except for the presence of increased surgical risk due to systemic disease, advanced age, idiosyncratic reaction to general anesthesia, or for those patients who refuse surgery. 2.Ursodiol is indicated for the prevention of gallstone formation in obese patients experiencing rapid weight loss.
New Indication
Treatment of cystic fibrosis liver disease.

Cyclosporine 2% ophthalmic ointment

Original Indication
Increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with deratoconjunctivites sicca.
New Indication
Treatment of severe keratoconjunctivitis sicca associated with Sjogren's syndrome.

Doxorubicin

Original Indication
1. Doxorubicin has been used successfully to produce regression in disseminated neoplastic conditions such as breast carcinoma, transitional cell bladder carcinoma, thyroid carcinoma, gastric carcinoma, 2. Doxorubicin is also indicated for use as a component of adjuvant therapy in women with evidence of axillary lymph node involvement following resection of primary breast cancer.
New Indication
Treatment of hepatocellular carcinoma.

Liposomal doxorubicin hydrochloride

Original Indication
DOXIL (doxorubicin HCl liposome injection) is an anthracycline topoisomerase inhibitor indicated for: 1. Ovarian cancer - After failure of platinum-based chemotherapy. 2. AIDS-related Kaposi's Sarcoma -after failure of prior combination chemotherapy or intolerance to such therapy. 3. Multiple Myeloma - In combination with bortezomib in patients who have not previously received bortezomib and have received at least one prior therapy.
New Indication
Treatment of soft tissue sarcomas.

Eflornithine HCl

Original Indication
Treatment of African trypanosomiasis (sleeping sickness), including the West African form (Trypanosoma brucei gambiense).
New Indication
Treatment of Pneumocystis carinii pneumonia in AIDS patients.

Epoetin alpha

Original Indication
Treatment of anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitantly administered chemotherapy.
New Indication
Treatment of myelodysplastic syndrome.

Erlotinib Hydrochloride

Original Indication
Treatment of locally advanced or metastatic non-small cell lung cancer after failure of at least one prior chemotherapy regimen.
New Indication
Treatment of malignant gliomas.

Etanercept

Original Indication
1. Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in patients with moderately to severely active rheumatoid arthritis. 2. Reducing signs and symptoms, inhibiting the progression of structural damage of active arthritis, and improving physical function in patients with psoriatic arthritis. 3. Reducing signs and symptoms in patients with active ankylosing spondylitis. 4. Treatment of adult patients (18 years or older) with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
New Indication
Treatment of Wegener's granulomatosis.

Etidronate disodium

Original Indication
Treatment of hypercalcemia in late-stage cancer patients.
New Indication
Treatment of degenerative metabolic bone disease occurring in patients who require long term (6 months or greater) total parenteral nutrition.

Everolimus

Original Indication
Prophylaxis of organ rejection in adult patients at low-moderate immunologic risk receiving a kidney transplant.
New Indication
Treatment of gastroenteropancreatic neuroendocrine tumors.

Histrelin

Original Indication
Vantas (Histrelin implant) is indicated in the palliative treatment of advanced prostate cancer.
New Indication
Treatment of acute intermittent porphyria, hereditary coproporphyria, and variegate porphyria.

Immuneglobulin Intravenous (Human)

Original Indication
For prophylaxis of children with clinical or immunologic evidence of human immunodeficiency virus to decrease the frequency of serious and minor bacterial infections and the frequency of hospitalization, and to increase the time free of serious bacterial infection.
New Indication
Treatment of juvenile rheumatoid arthritis.

Infliximab

Original Indication
Treatment of moderately to severely active Crohn's disease for the reduction of the signs and symptoms, in patients who have an inadequate response to conventional therapies; and treatment of patients with fistulizing Crohn's disease for the reduction in the number of draining enterocutaneous fistula(s).
New Indication
Treatment of juvenile rheumatoid arthritis.

Interferon alfa-2a (recombinant)

Original Indication
Roferon-A is indicated for chronic phase, Philadelphia chromosome positive chronic myelogenous leukemia patients who are minimally pretreated (within 1 year of diagnosis).
New Indication
For use in combination with fluorouracil for the treatment of esophageal carcinoma.

Peginterferon alfa-2a

Original Indication
1. PEGASYS, peginterferon alfa-2a, alone or in combination with COPEGUS, is indicated for the treatment of adults with chronic hepatitis C virus infection who have compensated liver disease and have not been previously treated with interferon alpha. Patients in whom efficacy was demonstrated included patients with compensated liver disease and histological evidence of cirrhosis (Child-Pugh class A) and patients with HIV disease that is clinically stable (e.g, antiretroviral therapy not required or receiving stable antiretroviral therapy).2.PEGASYS is indicated for the treatment of adult patients with HBeAg positive and HBeAg negative chronic hepatitis B who have compensated liver disease and evidence of viral replication and liver inflammation.
New Indication
Treatment of chronic myelogenous leukemia.

Interferon alfa-2b (recombinant)

Original Indication
INTRON A is indicated for the treatment of selected patients 18 years of age or older with AIDS-Related Kaposi's Sarcoma.
New Indication
Treatment of chronic myelogenous leukemia.

Peginterferon alfa-2b

Original Indication
PegIntron is an antiviral indicated for: 1. Combination therapy with REBETOL (ribavirin): Chronic Hepatitis C (CHC) in patients 3 years with compensated liver disease. 2. Monotherapy: CHC in patients ( 18 years) with compensated liver disease previously untreated with interferon alpha.
New Indication
Treatment of chronic delta hepatitis.

Metronidazole (topical)

Original Indication
Treatment of acne rosacea.
New Indication
Treatment of grade III and IV, anaerobically infected, decubitus ulcers.

Metronidazole

Original Indication
Metronidazole is indicated for treatment of Trichomoniasis (both symptomatic and asymptomatic), Asymptomatic consorts and anaerobi bacteria infections (see details at:http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=4767#nlm34067-9).
New Indication
Treatment of pouchitis.

Paclitaxel

Original Indication
Paclitaxel is indicated for the adjuvant treatment of node-positive breast cancer administered sequentially to standard doxorubicin-containing combination chemotherapy.
New Indication
Treatment of pancreatic cancer.

Paclitaxel aqueous gel

Original Indication
Paclitaxel is indicated for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy.
New Indication
Treatment of esophageal cancer.

Paclitaxel protein-bound particles for injection suspension

Original Indication
ABRAXANE for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) is indicated for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated.
New Indication
Treatment of stage IIb to IV melanoma.

Synthetic human secretin

Original Indication
For use in the diagnosis of gastrinoma associated with Zollinger-Ellison syndrome.
New Indication
For use in obtaining desquamated pancreatic cells for cytopathologic examination in pancreatic carcinoma.

Synthetic porcine secretin

Original Indication
For use in secretin stimulation testing for: Stimulation of pancreatic secretions to facilitate the identification of the ampulla of Vater and accessory papilla during endoscopic retrograde cholangio-pancreatography (ERCP).
New Indication
For use in obtaining desquamated pancreatic cells for cytopathologic examination in pancreatic carcinoma.

Temozolomide

Original Indication
Treatment of adult patients with refractory anaplastic astrocytoma, i.e, patients at first relapse who have experienced disease progression on a drug regimen containing a nitrosourea and procarbazine.
New Indication
Treatment of advanced metastatic melanoma.

Tetrabenazine

Original Indication
Treatment of chorea associated with Huntington's disease.
New Indication
Treatment of moderate/severe tardive dyskinesia.

Thalidomide

Original Indication
Acute treatment of the cutaneous manifestations of moderate to severe erythema nodosum leprosum (ENL) and as maintenance therapy for prevention and suppression of the cutaneous manifestations of ENL recurrences.
New Indication
Treatment of graft versus host disease in patients receiving bone marrow transplantation.

Tobramycin

Original Indication
TOBI is indicated for the management of cystic fibrosis patients with Pseudomonas aeruginosa.
New Indication
Treatment of bronchiectasis patients infected with Pseudomonas aeruginosa.

Liposomal topotecan hydrochloride

Original Indication
HYCAMTIN for Injection is a topoisomerase inhibitor indicated for:1. metastatic carcinoma of the ovary after failure of initial or subsequent chemotherapy. 2. small cell lung cancer sensitive disease after failure of first-line chemotherapy. 3. combination therapy with cisplatin for stage IV-B, recurrent, or persistent carcinoma of the cervix which is not amenable to curative treatment with surgery and/or radiation therapy.
New Indication
Treatment of gliomas.

Tretinoin

Original Indication
Tretinoin capsule is indicated for induction of remission in patients with acute promyelocytic leukemia who are refractory to or unable to tolerate anthracycline based cytotoxic chemotherapeutic regimens.
New Indication
Treatment of squamous metaplasia of the ocular surface epithelia (conjunctiva and/or cornea) with mucous deficiency and keratinization.

Trimetrexate

Original Indication
Concurrent leucovorin administration as an alternative therapy for the treatment of moderate to severe Pneumocystis carinii pneumonia in immunocompromised patients including patients with the acquired immunodeficiency syndrome, who are intolerant of, or are refractory to, trimethoprim-sulfamethoxazole therapy or for whom trimethoprim-sulfamethoxazole is contraindicated.
New Indication
Treatment of metastatic carcinoma of the head and neck (i.e. buccal cavity, pharynx, and larynx).

Leflunomide

Original Indication
Arthiritis
New Indication
Myeloma

Memantine

Original Indication
Alzheimer
New Indication
Fibromyalgia

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