Browse the FDA Approved Drugs by Year
Browse 2008 FDA Approved Drugs by Month
January
Adalimumab
Abbott's Humira (adalimumab) Receives FDA Approval For Moderate to Severe Chronic Plaque Psoriasis
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
Natalizumab
FDA Approves Tysabri (natalizumab) to Treat Moderate-to-Severe Crohn's Disease
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Prednisolone Acetate (Oral Suspension)
Taro Receives FDA Approval of New Drug Application for Flo-Pred (Prednisolone Acetate Oral Suspension)
Somatropin
Cangene's Recombinant Human Growth Hormone Accretropin (somatropin (rDNA origin)) Approved by the U.S. Food and Drug Administration
Tadalafil
FDA Approves Cialis (tadalafil) for Once Daily Use for the Treatment of Erectile Dysfunction
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Thrombin Topical Bovine Origin
FDA Approves ZymoGenetics' Recothrom (Thrombin, topical (Recombinant))
February
Adalimumab
Abbott Receives FDA Approval for Humira (Adalimumab) for Polyarticular Juvenile Idiopathic Arthritis
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)
Bevacizumab
FDA Grants Accelerated Approval of Avastin (bevacizumab) in Combination With Paclitaxel Chemotherapy for First-Line Treatment of Advanced HER2-Negative Breast Cancer
Desvenlafaxine
FDA Approves Pristiq (desvenlafaxine) for the Treatment of Adult Patients with Major Depressive Disorder
Levocetirizine
FDA Approves Xyzal (levocetirizine dihydrochloride) Oral Solution for the Relief of Seasonal and Year Round Allergies and Chronic Idiopathic Urticaria
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
Palonosetron
FDA Approves Aloxi (palonosetron HCl) Injection for Prevention of Postoperative Nausea and Vomiting
Rilonacept
FDA Approves Arcalyst (rilonacept) - New Orphan Drug for Treatment of Cryopyrin-Associated Periodic Syndromes (CAPS)
March
Fibrin Sealant (Human)
FDA Approves Artiss (fibrin sealant (human)) Medical Adhesive to Treat Burn Patients
Levoleucovorin
FDA Approves New Drug Application for Fusilev (levoleucovorin), Spectrum's First Proprietary Oncology Drug
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
Methylnaltrexone Bromide
Progenics and Wyeth Announce FDA Has Approved Relistor (methylnaltrexone bromide)
Olopatadine Hydrochloride
Alcon's Patanase (olopatadine hydrochloride) Nasal Spray Approved by FDA for Treatment of Nasal Allergy Symptoms
Rotavirus Vaccine
FDA Approves Rotarix (rotavirus vaccine, live attenuated) Vaccine to Prevent Gastroenteritis Caused by Rotavirus
Sumatriptan Succinate And Naproxen Sodium
Treximet (sumatriptan and naproxen sodium) Tablets Approved by FDA for Acute Treatment of Migraine
May
Alvimopan Capsules
Adolor and GlaxoSmithKline Announce FDA Approval of Entereg (alvimopan) for the Management of Postoperative Ileus (POI)
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
Atomoxetine
FDA Approves Strattera (atomoxetine) for Maintenance of ADHD in Children and Adolescents
Calcipotriene And Betamethasone Dipropionate
FDA Approves Taclonex (calcipotriene and betamethasone dipropionate) Scalp - Once Daily Therapy for Treatment of Moderate to Severe Scalp Psoriasis
Phentolamine Mesylate
Novalar Pharmaceuticals, Inc. Receives FDA Approval for OraVerse (phentolamine mesylate)
Quetiapine
FDA Approves AstraZeneca's Seroquel (quetiapine) for Maintenance Treatment in Bipolar Disorder
June
Bortezomib
FDA Approves Velcade (Bortezomib) for Injection for Patients with Previously Untreated Multiple Myeloma
Dermal Filler
FDA Approves Evolence (dermal filler) , a New Generation Collagen-Based Facial Filler
Difluprednate Ophthalmic Emulsion
Sirion Therapeutics Announces FDA Approval of Durezol (difluprednate) for Treatment of Postoperative Ocular Inflammation and Pain
DTP Adsorbed
FDA Approves Kinrix (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine) - New Combination Vaccine for Children
Dutasteride
FDA Approves GlaxoSmithKline's Avodart (dutasteride) in Combination with Tamsulosin for the Treatment of Symptomatic Enlarged Prostate
Methyl Aminolevulinate Hydrochloride
Photocure Receives FDA Approval for Metvixia/Aktilite Photodynamic Therapy
Methylphenidate
FDA Approves Concerta (methylphenidate HCl) Extended-release Tablets for Treatment of ADHD (Attention Deficit Hyperactivity Disorder) in Adults
Rabeprazole
FDA Approves Aciphex (rabeprazole sodium) 20 mg for Short-Term Treatment of GERD in Adolescents
Repaglinide And Metformin
FDA Approves PrandiMet (Replaglinide and Metformin a Fixed-Dose Combination) Tablet for Treatment of Type 2 Diabetes
Ropinirole
U.S. FDA Approves Requip (ropinirole) XL, the First and Only Oral Once-Daily Non-Ergot Dopamine Agonist for Parkinson's Disease
Tipranavir
New Aptivus (tipranavir) Oral Solution Approved for Treatment-Experienced Pediatric and Adolescent HIV Patients
Triamcinolone
Allergan Receives U.S. Food and Drug Administration Approval for Trivaris (triamcinolone acetonide injectable suspension) 80 mg/mL
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
July
Amlodipine and Valsartan
FDA Exforge (amlodipine and valsartan) Approved for High Blood Pressure as First-Line Treatment
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
Valproic Acid
Noven Announces Final FDA Approval of Stavzor (valproic acid) for the Treatment of Bipolar Disorder, Seizures and Migraine Headaches
August
Azacitidine
Vidaza (azacitidine) Receives Expanded FDA Approval to Include Overall Survival in Higher-Risk MDS
Palonosetron
FDA Approves Aloxi (palonosetron HCl) Capsules for Prevention of Acute Chemotherapy-induced Nausea and Vomiting
Tenofovir
U.S. Food and Drug Administration Approves Viread (tenofovir disoproxil fumarate) for Chronic Hepatitis B in Adults
Tetrabenazine
Xenazine (Tetrabenazine) Approved by FDA for Patients with Chorea Associated with Huntington's Disease
September
Albuterol (Salbutamol)
Teva's ProAir HFA (albuterol sulfate), the Market Leading Albuterol Inhaler, Receives New Pediatric Indication
Atazanavir
FDA Approved the use of Reyataz (atazanavir sulfate) Boosted with Ritonavir, in Combination Therapy, for Previously Untreated HIV-1 Infected Adult Patients
Granisetron
FDA Approves Sancuso (granisetron), the First and Only Patch for Preventing Nausea and Vomiting in Cancer Patients Undergoing Chemotherapy
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
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
Iobenguane I 123 Injection
FDA Approves GE Healthcare's AdreView (Iobenguane I 123 Injection) Diagnostic Agent for Detecting Neuroendocrine Tumors in Children, Adults
Bendamustine hydrochloride
Cephalon Receives FDA Approval for Treanda (bendamustine hydrochloride) to Treat Patients with Relapsed Indolent Non-Hodgkin's Lymphoma
C- 1 esterase inhibitor
Cinryze Receives FDA Approval for Prophylaxis Against Hereditary Angioedema Attacks
Conivaptan
FDA Approves Astellas' Vaprisol (Conivaptan Hydrochloride Injection) Premixed in 5% Dextrose for the Treatment of Hyponatremia
Darunavir
U.S. Food and Drug Administration (FDA) Approves Prezista Once-Daily as Part of Combination Therapy for Treatment-Naive Adults with HIV-1
Fesoterodine Fumarate
Pfizer's Toviaz (fesoterodine fumarate) Receives FDA Approval for the Treatment of Overactive Bladder
Lacosamide
UCB's Vimpat Approved By U.S. FDA As Adjunctive Therapy for Partial Onset Seizures in Adults
Mesalamine(Mesalazine)
Apriso Granted FDA Marketing Approval for Maintenance of Remission of Ulcerative Colitis
Quetiapine
FDA Approves AstraZeneca’s Seroquel XR for the Treatment of Bipolar Depression and Bipolar Mania in the US
Silodosin
Watson Receives US FDA Approval for Rapaflo (silodosin) for the Treatment of Benign Prostatic Hyperplasia (BPH)
November
Conjugated Estrogens
FDA Approves Low-dose Regimen of Premarin Vaginal Cream (conjugated estrogens) to Treat Moderate to Severe Postmenopausal Dyspareunia - Painful Sexual Intercourse
Eltrombopag
FDA Approves Promacta (eltrombopag), the First Oral Medication to Increase Platelet Production for People With Serious Blood Disorder
Nicardipine
EKR Therapeutics Broadens Its Ready-to-Use Cardene (nicardipine) Product Offerings with FDA Approval of Double Concentration Premixed I.V. Bags
Synthetic Conjugated Estrogens-A
FDA Approves Duramed's Synthetic Conjugated Estrogens-A Vaginal Cream
Tapentadol
FDA Approves Tapentadol Immediate-Release Tablets for Relief of Moderate to Severe Acute Pain
December
Acetylcysteine
Cumberland Pharmaceuticals Reports FDA Approval for Updated Labeling of Acetadote (acetylcysteine)
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
Amiodarone
Prism Pharmaceuticals Receives FDA Approval of Nexterone (amiodarone HCl) for Life-Threatening Ventricular Fibrillation and Ventricular Tachycardia
Anthrax Vaccine Adsorbed
Emergent BioSolutions Receives FDA Approval for BioThrax (Anthrax Vaccine Adsorbed) Supplemental Biologics License Application
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
Degarelix
FDA Approves Ferring Pharmaceutical's Firmagon (degarelix) for Treatment of Advanced Prostate Cancer
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
Fludarabine
Antisoma Receives FDA Approval for Oforta (fludarabine phosphate) oral, Plans Commercialization Deal to Bring Drug to US Patients
Fospropofol
FDA Approves Lusedra (fospropofol disodium) Injection for Monitored Anesthesia Care (MAC) Sedation
Gadofosveset Trisodium Injection
EPIX Pharmaceuticals Announces FDA Approval of Vasovist (gadofosveset trisodium)
Imatinib
FDA Approves Gleevec (imatinib mesylate) to Prevent Recurrence of Rare Gastrointestinal Cancer
Tetanus-Diphtheria-Acellular Pertussis (Tdap)
FDA Approves GlaxoSmithKline Tetanus, Diphtheria, Whooping Cough Vaccine, Boostrix (tetanus, diphtheria, acellular pertussis vaccine (Tdap)), for Adults
Tramadol
Labopharm Announces FDA Approval of Once-Daily Ryzolt (tramadol) for Moderate to Moderately Severe Chronic Pain