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