Comprehensive list of FDA approved drugs by year. Drug information includes the drug name and indication of use.
January
FDA Approves Actemra (tocilizumab) for the Treatment of Moderately to Severely Active Rheumatoid Arthritis
HIV/AIDS Update - Atripla (efavirenz, emtricitabine and tenofovir disoproxil fumarate) label update reflects new efficacy, safety and resistance data in treatment experienced patients
FDA Approves
Ampyra (dalfampridine)to Improve Walking in Adults with Multiple Sclerosis
FDA Approves Novo-Nordisk's Diabetes Drug Victoza (liraglutide)
U.S. Food and Drug Administration Approves Labeling Update for Prezista (darunavir) To Include 96-Week Data in HIV-1 Infected Adult Patients
GSK's Tykerb (lapatinib ditosylate) Receives Accelerated Approval for First-Line Combination Treatment of Metastatic Breast Cancer
February
Labopharm Receives FDA Approval for Oleptro (trazodone)
Auxilium Announces U.S. Food and Drug Administration Approval for Xiaflex (collagenase clostridium histolyticum) for the Treatment of Dupuytren's Contracture
FDA Approves Once-A-Day Lamictal XR (lamotrigine) as Add-On Epilepsy Therapy for Primary Generalized Tonic-Clonic Seizures
FDA Approves
Crestor (rosuvastatin calcium) to Reduce Stroke, Heart Attack Risk
FDA Approves Benicar (olmesartan medoxomil) for the Treatment of High Blood Pressure in Children and Adolescents aged 6-16
Abbott Receives U.S. FDA Approval for Heat-Stable Norvir (ritonavir) Tablets
FDA Approves Rituxan (rituximab) to Treat Chronic Lymphocytic Leukemia
Novartis Gets US Approval for
Menveo (meningococcal conjugate vaccine) Meningitis Vaccine
U.S. Food and Drug Administration Approves Cayston (Aztreonam for Inhalation Solution) for the Improvement of Respiratory Symptoms in Cystic Fibrosis Patients with Pseudomonas Aeruginosa
FDA Approves Prevnar 13 (pneumococcal 13-valent conjugate vaccine) Pneumococcal Disease Vaccine
FDA Approves
VPRIV (velaglucerase alfa) to Treat Gaucher Disease
FDA Expands Use of
Prevnar 13 (pneumococcal 13-valent conjugate vaccine)Vaccine for People Ages 50 and Older
March
FDA Approves Exaglo (hydromorphone HCl) Extended-Release Tablets
Novo Nordisk Receives FDA Approval for Norditropin FlexPro for Growth Hormone Treatment
CSL Behring Receives FDA Approval of Hizentra, First 20 Percent Subcutaneous Immunoglobulin Therapy
Botox (onabotulinumtoxinA) Receives FDA Approval for Treatment of Upper Limb Spasticity in Adults
FDA Approves Five-Day Dosing Regimen for Dacogen (decitabine) for Injection, Offering a New Outpatient Dosing Option for Myelodysplastic Syndromes (MDS)
FDA Approves Watson's Trelstar 22.5 mg, the First and Only 6-Month Intramuscular GnRH Agonist for the Palliative Treatment of Advanced Prostate Cancer
Somaxon Announces FDA Approval of Silenor (doxepin) for the Treatment of Insomnia
FDA Approves Carbaglu to Treat Condition That Causes Elevated Ammonia Levels
Galderma Received FDA Approval of Differin (adapalene) Lotion, 0.1%, the First Retinoid Available in Lotion Formulation
Once-Daily Mirapex ER Now Approved by FDA for Both Early and Advanced Parkinson's Disease
FDA Approves New Use of Xifaxan for Patients with Liver Disease
FDA Approves Zyclara (imiquimod) Cream, 3.75% for the Treatment of Actinic Keratoses
FDA Approves Asclera to Treat Small Varicose Veins
FDA Approves Zyclara (imiquimod) Cream, 3.75% for the Treatment of External Genital Warts
FDA Approves Zyclara (imiquimod) Cream, 2.5% for the Treatment of Actinic Keratoses
April
FDA Approves New Formulation for OxyContin (oxycodone)
Pancrelipase
FDA Approves Pancreatic Enzyme Product, Pancreaze (pancrelipase)
FDA Approves Oravig (miconazole) Buccal Tablets for Treatment of Oropharyngeal Candidiasis
FDA Approves
Tarceva (erlotinib) as a Maintenance Therapy for Advanced Non-Small Cell Lung Cancer
CSL Behring Receives FDA Approval to Extend Shelf Life for Privigen (immune globulin intravenous (human)) from 24 to 36 Months
Novartis Receives US FDA Approval for Zortress (everolimus) to Prevent Organ Rejection in Adult Kidney Transplant Recipients
Abbott Receives FDA Approval for Once-Daily Dosing of Kaletra (lopinavir / ritonavir) for Treatment-Experienced Patients
FDA Approves Provenge (sipuleucel-T) - a Cellular Immunotherapy for Men With Advanced Prostate Cancer
FDA Approved Vimovo for Arthritis Patients At Risk of Developing NSAID-Associated Gastric Ulcers
May
Pancrelipase
Abbott Receives FDA Approval for Creon (pancrelipase) to Include Dosing Information for Patients With Chronic Pancreatitis and Pancreatectomy
FDA Approves Natazia (dienogest and estradiol valerate) - New Combination Product Oral Contraceptive
Allergan Receives FDA Approval for Zymaxid (gatifloxacin) Ophthalmic Solution
FDA Approves Lumizyme (alglucosidase alfa) for Late-Onset Pompe Disease
Cysview (Hexaminolevulinate HCl) Approved by the FDA for Cystoscopic Detection of Papillary Bladder Cancer
June
FDA Approves Amgen's Prolia (Denosumab) for Treatment of Postmenopausal Women With Osteoporosis at High Risk for Fracture
FDA approves Jalyn (dutasteride and tamsulosin) , a fixed-dose combination of dutasteride and tamsulosin, for symptomatic BPH in men with an enlarged prostate
Jevtana (cabazitaxel) Injection Approved by U.S. FDA After Priority Review
Novartis International AG (CH) - FDA approves
Tasigna (nilotinib) for newly diagnosed chronic myeloid leukemia patients, data demonstrate major advance over Glivec
FDA approves Staxyn (vardenafil HCl) orally disintegrating tablets for erectile dysfunction (ED)
Forest and Merz Announce FDA Approval of
Namenda (memantine hydrochloride) XR for the Treatment of Moderate to Severe Dementia of the Alzheimer's Type
FDA Approves Lucentis (Ranibizumab Injection) for the Treatment of Macular Edema Following Retinal Vein Occlusion
FDA Approves Merck's Dulera (mometasone furoate and formoterol fumarate dihydrate) Inhalation Aerosol for the Treatment of Asthma in Patients 12 Years of Age and Older
Purdue Pharma L.P. Receives FDA Approval for Butrans (buprenorphine) Transdermal System CIII
FDA Approves Alsuma (sumatriptan) Auto-Injector
FDA Approves New Indications for Prolia (denosumab) for the Treatment of Bone Loss in Patients With Prostate or Breast Cancer Undergoing Hormone Ablation Therapy
July
FDA Approves Strativa Pharmaceuticals' Zuplenz (ondansetron) Oral Soluble Film
Three Rivers Pharmaceuticals Announces FDA Approval Of Expanded Labeling of Infergen (interferon alfacon-1)
Kamada Wins FDA Approval for Glassia (alpha1-proteinase inhibitor (human)) - a New Liquid, Ready-to-Use Treatment for Alpha-1 Antitrypsin Deficiency
FDA Approves Daytrana (methylphenidate transdermal system) CII for the Treatment of ADHD in Adolescents
Stiefel, a GSK company, Receives FDA Approval of Veltin (clindamycin phosphate and tretinoin) Gel 1.2%/0.025%
Eisai Inc. and Pfizer Inc Announce U.S. FDA Approval for New Higher-Dose Aricept (donepezil HCl) 23 mg Tablet for the Treatment of Moderate-to-Severe Alzheimer's Disease
Amlodipine , Hydrochlorothiazide and Olmesartan
FDA Approves Tribenzor (amlodipine, hydrochlorothiazide and olmesartan) , A New Three-In-One Combination Product for the Treatment of High Blood Pressure
FDA Approves Lastacaft (alcaftadine ophthalmic solution) for Prevention of Itching Associated with Allergic Conjunctivitis
Glycopyrolate
FDA Approves Cuvposa (glycopyrrolate) for Chronic Drooling in Children
Abbott's Simcor (niacin extended-release/simvastatin) Receives FDA Approval for New Dosage Strengths
August
FDA Approves New Taxotere (docetaxel) Injection Concentrate Formulation
FDA Approves Suprep (sodium sulfate, potassium sulfate, magnesium sulfate) Bowel Prep Kit
FDA Approves Longer Use of Valcyte (valganciclovir) for Adult Kidney Transplant Patients at High Risk of Developing Cytomegalovirus (CMV) Disease
FDA Approves ella (ulipristal acetate) Tablets for Prescription Emergency Contraception
Novartis receives FDA approval of Tekamlo (aliskiren and amlodipine), a single-pill combination of aliskiren and amlodipine to treat high blood pressure
Reckitt Benckiser Pharmaceuticals Inc. Receives FDA Approval for Suboxone (buprenorphine and naloxone) Sublingual Film C-III
September
Merck Receives Approval from FDA for Expanded Indications for Atypical Antipsychotic Medication Saphris (asenapine) Sublingual Tablets
FDA Approves New Dosing for Faslodex (fulvestrant) Injection in Treatment of Metastatic Breast Cancer in HR+ Postmenopausal Women
FDA Approves Pediatric Use of
Protopam Chloride (pralidoxime chloride) Chemical Poisoning Treatment
FDA Approves Krystexxa (pegloticase) for Gout
Novartis Gains FDA Approval For Gilenya (fingolimod), A Novel First-Line Multiple Sclerosis Treatment Shown To Significantly Reduce Relapses And Delay Disability Progression
Dexamethasone Ophthalmic
Allergan Receives FDA Approval for Ozurdex (dexamethasone) as Treatment Option for Non-Infectious Uveitis Affecting the Posterior Segment of the Eye
Shionogi Announces FDA Approval of Kapvay (clonidine hydrochloride) - The First and Only Therapy Approved for Use with Stimulant Medication for the Treatment of ADHD
Allergan, Inc. Receives FDA Approval for Lumigan 0.01% as First-Line Therapy Indicated for the Reduction of Elevated Intraocular Pressure in Glaucoma Patients
October
United States Food and Drug Administration Approves Aridol (mannitol)
Warner Chilcott Announces FDA Approval of Atelvia (risedronate sodium) Next Generation Actonel
Stiefel, a GSK company, Receives FDA Approval of Sorilux (calcipotriene) Foam, 0.005%
FDA Approves Vivitrol (naltrexone) to Treat Opioid-dependent Patients
Immune Globulin Intravenous And Subcutaneous
Talecris Biotherapeutics Receives FDA Approval for Gamunex-C (immune globulin intravenous and subcutaneous)
FDA Approves H.P. Acthar Gel (corticotropin) for the Treatment of Infantile Spasms
U.S. Food and Drug Administration Approves Baraclude (entecavir) as a Treatment for Chronic Hepatitis B Patients with Evidence of Decompensated Liver Disease
FDA Approves Pradaxa (dabigatran etexilate) to Prevent Stroke in People With Atrial Fibrillation
ISTA Pharmaceuticals Receives FDA Approval for Bromday (bromfenac)
Warner Chilcott Announces FDA Approval of New Oral Contraceptive Lo Loestrin Fe (norethindrone acetate and ethinyl estradiol tablets, ethinyl estradiol tablets and ferrous fumarate)
FDA approves additional medical indication for Sprycel (dasatinib)
FDA approves Latuda (lurasidone) to treat schizophrenia in adults
Avanir Pharmaceuticals Announces FDA Approval of Nuedexta (dextromethorphan and quinidine)
FDA Approves Teflaro (ceftaroline fosamil) for Bacterial Infections
FDA Approves New Indication for Afinitor (everolimus)
November
Acetaminophen
Cadence Pharmaceuticals Announces FDA Approval of Ofirmev (acetaminophen) injection for the Management of Pain and Fever
FDA Clears Cymbalta (duloxetine) to Treat Chronic Musculoskeletal Pain
Kombiglyze XR (Saxagliptin and Metformin HCl Extended-Release) Tablets Approved in the U.S. for the Treatment of Type 2 Diabetes Mellitus in Adults
FDA Approves Egrifta (tesamorelin for injection): First and Only Treatment for the Reduction of Excess Abdominal Fat in HIV-infected Patients with Lipodystrophy
FDA Approves Vyvanse (lisdexamfetamine dimesylate) Capsules CII for the Treatment of ADHD in Adolescents
FDA Approves Halaven (eribulin mesylate) for Late-Stage Breast Cancer
FDA Approves Amgen's Xgeva (denosumab) for the Prevention of Skeletal-Related Events in Patients with Bone Metastases from Solid Tumors
Prism Pharmaceuticals Receives FDA Approval of Ready-to-Use Nexterone (Amiodarone HCl) Premixed Injection
FDA Approves Moxeza (moxifloxacin) for Bacterial Conjunctivitis
FDA Approves Movement Disorder Drug from CNS Therapeutics: Gablofen (Baclofen Injection) for the Treatment of Severe Spasticity
Lilly and Acrux Receive FDA Approval for Axiron (Testosterone) Topical Solution CIII
December
Cubist Pharmaceuticals Receives FDA Approval for 2-Minute IV Injection of Cubicin (daptomycin )
FDA Approves Prezista (darunavir) Once-Daily Dosing for HIV-1 Treatment-Experienced Adults With No Darunavir Resistance-Associated Mutations
Novartis Gains FDA Approval for Amturnide (aliskiren, amlodipine and hydrochlorothiazide), a Triple-Combination Pill to Treat High Blood Pressure in Patients Uncontrolled on Two Medications
Endo Pharmaceuticals Receives FDA Approval for Fortesta (Testosterone) Gel as a Class III Product for Topical Use for Men With Low Testosterone
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