| January | February | March | April |
| May | June | July | August |
| September | October | November | December |
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Tadalafil
FDA Approves Cialis (tadalafil) for Once Daily Use for the Treatment of Erectile Dysfunction |
Natalizumab
FDA Approves Tysabri (natalizumab) to Treat Moderate-to-Severe Crohn's Disease |
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Ciclesonide
Alvesco (ciclesonide) Gains FDA Approval for the U.S. Market |
Prednisolone Acetate (Oral Suspension)
Taro Receives FDA Approval of New Drug Application for Flo-Pred (Prednisolone Acetate Oral Suspension) |
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Thrombin Topical Bovine Origin
FDA Approves ZymoGenetics' Recothrom (Thrombin, topical (Recombinant)) |
Adalimumab
Abbott's Humira (adalimumab) Receives FDA Approval For Moderate to Severe Chronic Plaque Psoriasis |
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Etravirine
FDA Approves Intelence (etravirine) for HIV Combination Therapy |
Aliskiren And Hydrochlorothiazide
Tekturna HCT (aliskiren and hydrochlorothiazide) , a Single-Tablet Combination of Tekturna and a Diuretic, Receives US Approval for Treatment of High Blood Pressure |
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Micafungin
FDA Approves Additional Indication for Astellas' Mycamine (micafungin sodium) |
Somatropin
Cangene's Recombinant Human Growth Hormone Accretropin (somatropin (rDNA origin)) Approved by the U.S. Food and Drug Administration |
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Mometasone
FDA Approves Asmanex Twisthaler (Mometasone Furoate Inhalation Powder) for the Once Daily Maintenance Treatment of Asthma in Children Ages 4-11 |
Niacin Er And Simvastatin
Abbott Receives FDA Approval for Simcor (Niaspan / simvastatin), a Novel Combination Medicine for Comprehensive Cholesterol Management |
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Levocetirizine
FDA Approves Xyzal (levocetirizine dihydrochloride) Oral Solution for the Relief of Seasonal and Year Round Allergies and Chronic Idiopathic Urticaria |
Antihemophiliac factor
FDA Licenses Xyntha (antihemophilic factor (recombinant), plasma/albumin free ) a New Hemophilia Treatment |
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Adalimumab
Abbott Receives FDA Approval for Humira (Adalimumab) for Polyarticular Juvenile Idiopathic Arthritis |
Bevacizumab
FDA Grants Accelerated Approval of Avastin (bevacizumab) in Combination With Paclitaxel Chemotherapy for First-Line Treatment of Advanced HER2-Negative Breast Cancer |
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Esomeprazole
FDA Approves Nexium (esomeprazole) for Use in Children Ages 1-11 Years |
Rilonacept
FDA Approves Arcalyst (rilonacept) - New Orphan Drug for Treatment of Cryopyrin-Associated Periodic Syndromes (CAPS) |
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Aripiprazole
U.S. Food and Drug Administration Approves Abilify (aripiprazole) for the Acute Treatment of Manic and Mixed Episodes Associated With Bipolar I Disorder in Pediatric Patients (10 to 17 Years of Age) |
Desvenlafaxine
FDA Approves Pristiq (desvenlafaxine) for the Treatment of Adult Patients with Major Depressive Disorder |
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Palonosetron
FDA Approves Aloxi (palonosetron HCl) Injection for Prevention of Postoperative Nausea and Vomiting |
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Levoleucovorin
FDA Approves New Drug Application for Fusilev (levoleucovorin), Spectrum's First Proprietary Oncology Drug |
Fibrin Sealant (Human)
FDA Approves Artiss (fibrin sealant (human)) Medical Adhesive to Treat Burn Patients |
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Rotavirus Vaccine
FDA Approves Rotarix (rotavirus vaccine, live attenuated) Vaccine to Prevent Gastroenteritis Caused by Rotavirus |
Regadenoson
CV Therapeutics and Astellas Announce FDA Approval for Lexiscan (regadenoson) Injection |
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Olopatadine Hydrochloride
Alcon's Patanase (olopatadine hydrochloride) Nasal Spray Approved by FDA for Treatment of Nasal Allergy Symptoms |
Sumatriptan Succinate And Naproxen Sodium
Treximet (sumatriptan and naproxen sodium) Tablets Approved by FDA for Acute Treatment of Migraine |
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Certolizumab
Cimzia (certolizumab pegol) Approved in the US for the Treatment of Moderate to Severe Crohn's Disease |
Lisdexamfetamine
FDA Approves Vyvanse (lisdexamfetamine dimesylate), the First and Only Once-Daily Prodrug Stimulant to Treat ADHD in Adults |
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Bupropion
Biovail Receives FDA Approval for Aplenzin (bupropion hydrobromide) |
Methylnaltrexone Bromide
Progenics and Wyeth Announce FDA Has Approved Relistor (methylnaltrexone bromide) |
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Atomoxetine
FDA Approves Strattera (atomoxetine) for Maintenance of ADHD in Children and Adolescents |
Aripiprazole
U.S. Food and Drug Administration Approves Abilify (aripiprazole) for Add-On Treatment to Lithium or Valproate in the Acute Treatment of Adults With Manic and Mixed Episodes of Bipolar I Disorder With or Without Psychotic Features |
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Phentolamine Mesylate
Novalar Pharmaceuticals, Inc. Receives FDA Approval for OraVerse (phentolamine mesylate) |
Calcipotriene And Betamethasone Dipropionate
FDA Approves Taclonex (calcipotriene and betamethasone dipropionate) Scalp - Once Daily Therapy for Treatment of Moderate to Severe Scalp Psoriasis |
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Quetiapine
FDA Approves AstraZeneca's Seroquel (quetiapine) for Maintenance Treatment in Bipolar Disorder |
Alvimopan Capsules
Adolor and GlaxoSmithKline Announce FDA Approval of Entereg (alvimopan) for the Management of Postoperative Ileus (POI) |
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Rabeprazole
FDA Approves Aciphex (rabeprazole sodium) 20 mg for Short-Term Treatment of GERD in Adolescents |
Zoledronic Acid
FDA broadens US indication for once-yearly Reclast (zoledronic acid) as only osteoporosis treatment approved for prevention of fractures after a hip fracture |
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Ropinirole
U.S. FDA Approves Requip (ropinirole) XL, the First and Only Oral Once-Daily Non-Ergot Dopamine Agonist for Parkinson's Disease |
Duloxetine
FDA Approves Cymbalta (duloxetine) for the Management of Fibromyalgia |
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Triamcinolone
Allergan Receives U.S. Food and Drug Administration Approval for Trivaris (triamcinolone acetonide injectable suspension) 80 mg/mL |
Dutasteride
FDA Approves GlaxoSmithKline's Avodart (dutasteride) in Combination with Tamsulosin for the Treatment of Symptomatic Enlarged Prostate |
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Bortezomib
FDA Approves Velcade (Bortezomib) for Injection for Patients with Previously Untreated Multiple Myeloma |
Repaglinide And Metformin
FDA Approves PrandiMet (Replaglinide and Metformin a Fixed-Dose Combination) Tablet for Treatment of Type 2 Diabetes |
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Difluprednate Opthalmic Emulsion
Sirion Therapeutics Announces FDA Approval of Durezol (difluprednate) for Treatment of Postoperative Ocular Inflammation and Pain |
Tipranavir
New Aptivus (tipranavir) Oral Solution Approved for Treatment-Experienced Pediatric and Adolescent HIV Patients |
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DTP Adsorbed
FDA Approves Kinrix (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine) - New Combination Vaccine for Children |
Methylphenidate
FDA Approves Concerta (methylphenidate HCl) Extended-release Tablets for Treatment of ADHD (Attention Deficit Hyperactivity Disorder) in Adults |
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Methyl Aminolevulinate Hydrochloride
Photocure Receives FDA Approval for Metvixia/Aktilite Photodynamic Therapy |
Dermal Filler
FDA Approves Evolence (dermal filler) , a New Generation Collagen-Based Facial Filler |
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Gadoxetate Disodium Injection
FDA Approves Eovist (gadoxetate disodium) to Detect and Characterize Focal Liver Lesions |
Hypromellose, Dextrose and Glutathione
FDA Approves Navstel (balanced salt ophthalmic solution with hypromellose, dextrose and glutathione) Intraocular Irrigating Solution |
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Valproic Acid
Noven Announces Final FDA Approval of Stavzor (valproic acid) for the Treatment of Bipolar Disorder, Seizures and Migraine Headaches |
Nicardipine
FDA Approves Cardene (nicardipine) a New Cardene Formulation |
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Amlodipine and Valsartan
FDA Exforge (amlodipine and valsartan) Approved for High Blood Pressure as First-Line Treatment |
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Clevidipine
The Medicines Company’s Cleviprex (clevidipine butyrate) Receives FDA Approval |
Tenofovir
U.S. Food and Drug Administration Approves Viread (tenofovir disoproxil fumarate) for Chronic Hepatitis B in Adults |
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Tetrabenazine
Xenazine (Tetrabenazine) Approved by FDA for Patients with Chorea Associated with Huntington's Disease |
Azacitidine
Vidaza (azacitidine) Receives Expanded FDA Approval to Include Overall Survival in Higher-Risk MDS |
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Romiplostim
FDA Approves Nplate (romiplostim) for Long-Term Treatment of Adult Chronic ITP |
Palonosetron
FDA Approves Aloxi (palonosetron HCl) Capsules for Prevention of Acute Chemotherapy-induced Nausea and Vomiting |
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Insulin Aspart
FDA Approves Novolog Mix (insulin aspart and insulin aspart protamine) |
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Human Papillomavirus Quadrivalent
FDA Approves Expanded Uses for Gardasil (human papillomavirus quadrivalent (types 6, 11, 16, and 18) vaccine, recombinant to Include Preventing Certain Vulvar and Vaginal Cancers |
Granisetron
FDA Approves Sancuso (granisetron), the First and Only Patch for Preventing Nausea and Vomiting in Cancer Patients Undergoing Chemotherapy |
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Levetiracetam
Keppra (levetiracetam) XR Approved in the U.S. |
Immune Globulin Intravenous
FDA Grants Approval to Talecris Biotherapeutics for Gamunex (immune globulin intravenous (human)) as a Treatment for Neurological Disorder CIDP in the United States |
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Iobenguane I 123 Injection
FDA Approves GE Healthcare's AdreView (Iobenguane I 123 Injection) Diagnostic Agent for Detecting Neuroendocrine Tumors in Children, Adults |
Albuterol (Salbutamol)
Teva's ProAir HFA (albuterol sulfate), the Market Leading Albuterol Inhaler, Receives New Pediatric Indication |
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Pemetrexed
FDA Grants Lilly's Alimta (Pemetrexed for Injection) Third U.S. Approval |
Atazanavir
FDA Approved the use of Reyataz (atazanavir sulfate) Boosted with Ritonavir, in Combination Therapy, for Previously Untreated HIV-1 Infected Adult Patients |
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Lidocaine
Akorn, Inc. Announces the FDA Approval of Akten Ophthalmic Gel 3.5% |
Silodosin
Watson Receives US FDA Approval for Rapaflo (silodosin) for the Treatment of Benign Prostatic Hyperplasia (BPH) |
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Risperidone
FDA Approves New Injection Site for Risperdal Consta for Schizophrenia Treatment |
Quetiapine
FDA Approves AstraZeneca’s Seroquel XR for the Treatment of Bipolar Depression and Bipolar Mania in the US |
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C- 1 esterase inhibitor
Cinryze Receives FDA Approval for Prophylaxis Against Hereditary Angioedema Attacks |
Azelastine
FDA Approves Astepro |
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Benzoyl Peroxide And Clindamycin Phosphate
FDA Approves Acanya |
Darunavir
U.S. Food and Drug Administration (FDA) Approves Prezista Once-Daily as Part of Combination Therapy for Treatment-Naive Adults with HIV-1 |
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Conivaptan
FDA Approves Astellas' Vaprisol (Conivaptan Hydrochloride Injection) Premixed in 5% Dextrose for the Treatment of Hyponatremia |
Ethinyl Estradiol And Levonorgestrel
FDA Approves Duramed's LoSeasonique Oral Contraceptive |
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Insulin Glulisine
FDA Approves Rapid-Acting Insulin Apidra for Treatment of Children with Diabetes |
Lacosamide
UCB's Vimpat Approved By U.S. FDA As Adjunctive Therapy for Partial Onset Seizures in Adults |
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Fesoterodine Fumarate
Pfizer's Toviaz (fesoterodine fumarate) Receives FDA Approval for the Treatment of Overactive Bladder |
Mesalamine(Mesalazine)
Apriso Granted FDA Marketing Approval for Maintenance of Remission of Ulcerative Colitis |
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Bendamustine hydrochloride
Cephalon Receives FDA Approval for Treanda (bendamustine hydrochloride) to Treat Patients with Relapsed Indolent Non-Hodgkin's Lymphoma |
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Eltrombopag
FDA Approves Promacta (eltrombopag), the First Oral Medication to Increase Platelet Production for People With Serious Blood Disorder |
Rosuvastatin
Crestor (rosuvastatin calcium) Approved for Primary Dysbetalipoproteinemia |
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Ranolazine
FDA Approves Ranexa (ranolazine) for First Line Anti Anginal Use |
Nicardipine
EKR Therapeutics Broadens Its Ready-to-Use Cardene (nicardipine) Product Offerings with FDA Approval of Double Concentration Premixed I.V. Bags |
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Conjugated Estrogens
FDA Approves Low-dose Regimen of Premarin Vaginal Cream (conjugated estrogens) to Treat Moderate to Severe Postmenopausal Dyspareunia - Painful Sexual Intercourse |
Rufinamide
FDA Approves Banzel (rufinamide) as Adjunctive Treatment for Severe Epilepsy Disorder |
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Tapentadol
FDA Approves Tapentadol Immediate-Release Tablets for Relief of Moderate to Severe Acute Pain |
Synthetic Conjugated Estrogens-A
FDA Approves Duramed's Synthetic Conjugated Estrogens-A Vaginal Cream |
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Tetanus-Diphtheria-Acellular Pertussis (Tdap)
FDA Approves GlaxoSmithKline Tetanus, Diphtheria, Whooping Cough Vaccine, Boostrix (tetanus, diphtheria, acellular pertussis vaccine (Tdap)), for Adults |
Fospropofol
FDA Approves Lusedra (fospropofol disodium) Injection for Monitored Anesthesia Care (MAC) Sedation |
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Fenofibric Acid
Abbott Receives FDA Approval for Trilipix (fenofibric acid), First and Only Fibrate Indicated for Use in Combination With a Statin for Cholesterol Management |
Plerixafor Injection
FDA Approves Genzyme's Mozobil (plerixafor) |
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Anthrax Vaccine Adsorbed
Emergent BioSolutions Receives FDA Approval for BioThrax (Anthrax Vaccine Adsorbed) Supplemental Biologics License Application |
Fludarabine
Antisoma Receives FDA Approval for Oforta (fludarabine phosphate) oral, Plans Commercialization Deal to Bring Drug to US Patients |
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Acetylcysteine
Cumberland Pharmaceuticals Reports FDA Approval for Updated Labeling of Acetadote (acetylcysteine) |
Imatinib
FDA Approves Gleevec (imatinib mesylate) to Prevent Recurrence of Rare Gastrointestinal Cancer |
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Zolpidem
NovaDel Pharma Receives FDA Approval of Zolpimist (zolpidem tartrate) |
Gadofosveset Trisodium Injection
EPIX Pharmaceuticals Announces FDA Approval of Vasovist (gadofosveset trisodium) |
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Degarelix
FDA Approves Ferring Pharmaceutical's Firmagon (degarelix) for Treatment of Advanced Prostate Cancer |
Bimatoprost
Allergan Announces U.S. Food and Drug Administration (FDA) Approval of Latisse (bimatoprost)- First and Only Treatment Approved by the FDA for Hypotrichosis of Eyelashes |
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Tramadol
Labopharm Announces FDA Approval of Once-Daily Ryzolt (tramadol) for Moderate to Moderately Severe Chronic Pain |
Amiodarone
Prism Pharmaceuticals Receives FDA Approval of Nexterone (amiodarone HCl) for Life-Threatening Ventricular Fibrillation and Ventricular Tachycardia |
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Adapalene And Benzoyl Peroxide
Galderma Announces Availability Of Epiduo (adapalene and benzoyl peroxide) The First And Only Combination Treatment With A Retinoid And Benzoyl Peroxide To Treat Acne |