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FDA Approved Drugs in 2008

Comprehensive list of FDA approved drugs by year. Drug information includes the drug name and indication of use.

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Browse the FDA Approved Drugs by year

2013     2012     2011     2010     2009     2008    

January February March April
May June July August
September October November December

January
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
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)
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
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
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

February
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
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
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
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)
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
Palonosetron
FDA Approves Aloxi (palonosetron HCl) Injection for Prevention of Postoperative Nausea and Vomiting

March
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

April
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
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
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
Bupropion
Biovail Receives FDA Approval for Aplenzin (bupropion hydrobromide)
Methylnaltrexone Bromide
Progenics and Wyeth Announce FDA Has Approved Relistor (methylnaltrexone bromide)

May
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
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
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)

June
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
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
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
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
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
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
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

July
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
Nicardipine
FDA Approves Cardene (nicardipine) a New Cardene Formulation
Amlodipine and Valsartan
FDA Exforge (amlodipine and valsartan) Approved for High Blood Pressure as First-Line Treatment

August
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
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
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
Insulin Aspart
FDA Approves Novolog Mix (insulin aspart and insulin aspart protamine)

September
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
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
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
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

October
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)
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
C- 1 esterase inhibitor
Cinryze Receives FDA Approval for Prophylaxis Against Hereditary Angioedema Attacks
Azelastine
FDA Approves Astepro
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
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
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
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
Bendamustine hydrochloride
Cephalon Receives FDA Approval for Treanda (bendamustine hydrochloride) to Treat Patients with Relapsed Indolent Non-Hodgkin's Lymphoma

November
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
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
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
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

December
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
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)
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
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
Zolpidem
NovaDel Pharma Receives FDA Approval of Zolpimist (zolpidem tartrate)
Gadofosveset Trisodium Injection
EPIX Pharmaceuticals Announces FDA Approval of Vasovist (gadofosveset trisodium)
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
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
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

Browse the FDA Approved Drugs by year

2013     2012     2011     2010     2009     2008    

January February March April
May June July August
September October November December
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