Comprehensive list of FDA approved drugs by year. Drug information includes the drug name and indication of use.
January
FDA Approves New Dosage Strength for
Intelence (etravirine)
FDA Approval for Abstral (Fentanyl) Sublingual Tablets
FDA Approves DaTscan (Ioflupane I 123 Injection) for Visualization of Dopamine Transporters in Patients with Suspected Parkinsonian Syndromes
FDA Approves Natroba (spinosad) Head Lice Treatment for Children and Adults
FDA Approves Viibryd (vilazodone) to Treat Major Depressive Disorder
FDA Approves Rituxan (rituximab) for First-Line Maintenance Use in Follicular Lymphoma
Depomed Announces US Food and Drug Administration Approval of Gralise (gabapentin) Once-Daily Tablets for Treatment of Post-Herpetic Neuralgia
February
FDA Approves Makena (hydroxyprogesterone caproate) to Reduce Risk of Preterm Birth in At-Risk Pregnant Women
Reyataz (atazanavir) label revised, adding dosing recommendations for pregnancy and postpartum period
Abilify (aripiprazole) Approved for Maintenance Treatment of Bipolar I Disorder as an Adjunct to Either Lithium or Valproate
FDA Approves Edarbi (azilsartan medoxomil) to Treat High Blood Pressure
FDA Approves Daliresp (roflumilast) to Treat Chronic Obstructive Pulmonary Disease
March
FDA Approves Banzel (rufinamide) Oral Suspension, 40 mg/mL
FDA Approves Benlysta (belimumab) to Treat Lupus
U.S. FDA Approves Bayer's Gadavist (gadobutrol) Injection for MRI of the Central Nervous System
FDA Expands Indication for Zostavax (zoster vaccine live), Merck's Shingles Vaccine, to Include Adults Ages 50 to 59
FDA Approves Zyclara (imiquimod) Cream, 3.75% for the Treatment of External Genital Warts
FDA Approves Yervoy (ipilimumab) for Late-Stage Melanoma
FDA Approves Viramune XR (nevirapine) 400 mg extended release tablet
FDA Approves Merck's Sylatron (peginterferon alfa-2b) for Injection, a New Adjuvant Treatment for Melanoma with Microscopic or Gross Nodal Involvement
April
FDA Approves Orphan Drug Caprelsa (vandetanib) for Advanced Medullary Thyroid Cancer
Paliperidone
Invega (paliperidone) Approved as Treatment for Schizophrenia in Adolescents
FDA Approves Rituxan (rituximab) to Treat Two Rare Disorders
FDA Approves Menactra (meningococcal conjugate vaccine) to Prevent Meningococcal Disease in Infants and Toddlers
Horizon Pharma Announces FDA Approval of Duexis (Ibuprofen/Famotidine)
FDA Approves Lamictal XR (Lamotrigine) for Conversion to Monotherapy for Treatment of Partial Seizures in Appropriate Patients
FDA Approves Zytiga (abiraterone) for Late-Stage Prostate Cancer
May
FDA Approves Fusilev (levoleucovorin) for Use in Patients with Colorectal Cancer
FDA Approves Nexium I.V. (Esomeprazole Sodium) for the Treatment of Gastroesophageal Reflux Disease (GERD) With Erosive Esophagitis in Pediatric and Adolescent Patients
FDA Approves Tradjenta (linagliptin) for Type 2 Diabetes
Novartis Gains FDA Approval for Afinitor (everolimus) As First New Treatment in Nearly Three Decades for Patients With Advanced Pancreatic NET
FDA Licenses
Fluzone (influenza virus vaccine, inactivated) Intradermal - Sanofi Pasteur's New Influenza Vaccine Delivered by Intradermal Microinjection
FDA Approves Merck's Victrelis (boceprevir), First-in-Class Oral Hepatitis C Virus (HCV) Protease Inhibitor
FDA Approves New HIV Treatment Edurant (rilpivirine)
FDA Approves Sutent (sunitinib malate) for Rare Type of Pancreatic Cancer
FDA Approves Incivek (telaprevir) for People with Hepatitis C
FDA Approves
Dificid (fidaxomicin) for Clostridium difficile Infection
June
FDA Approves Updates to Lilly's Humalog (insulin lispro injection [rDNA origin]) Label
Valeant and GlaxoSmithKline Announce U.S. FDA Approval of Potiga (ezogabine)
Pancrelipase
Abbott Receives FDA Approval for Creon (pancrelipase) Infant-Specific Dosage for Patients With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis
FDA Approves Nulojix (belatacept) for Kidney Transplant Patients
FDA Grants Accelerated Approval of Istodax (romidepsin) As Treatment for Patients with Peripheral T-Cell Lymphoma Who Have Received at Least One Prior Therapy
Pfizer and Acura Announce FDA Approval of Oxecta (Oxycodone HCl, USP) CII
Abbott Receives FDA Approval for a New Six-Month Formulation of Lupron Depot (leuprolide acetate for depot suspension) for the Palliative Treatment of Advanced Prostate Cancer
ProStrakan Receives FDA Approval for Rectiv (nitroglycerin) for the Treatment of Moderate to Severe Pain Associated With Chronic Anal Fissures
Fibrocell Science, Inc. Announces FDA Approval for laViv (azficel-T)
FDA Approves Zutripro (hydrocodone bitartrate, chlorpheniramine maleate and pseudoephedrine HCl) Oral Solution
FDA Approves Rezira (hydrocodone bitartrate and pseudoephedrine HCl) Oral Solution
July
FDA Approves Xarelto (rivaroxaban) to Prevent Deep Vein Thrombosis in Patients Undergoing Knee or Hip Replacement Surgery
FDA Approves Arcapta (indacaterol) Neohaler to treat Chronic Obstructive Pulmonary Disease
Lialda (Mesalamine) Now Approved in U.S. for Maintenance of Remission of Ulcerative Colitis
FDA approves blood-thinning drug Brilinta (ticagrelor) to treat acute coronary syndromes
Merz Aesthetics Announces FDA Approval Of Xeomin (incobotulinumtoxinA) For The Temporary Improvement In The Appearance Of Moderate To Severe Glabellar Lines In Adult Patients
Baxter Announces FDA Approval of Subcutaneous Route of Administration for Gammagard Liquid (immune globulin infusion (human)) for Patients with Primary Immunodeficiency
Once-Daily Welchol (colesevelam HCl) for Oral Suspension Receives FDA Approval To be Mixed With Fruit Juice or Diet Soft Drinks
FDA Approves Zyclara (imiquimod) Cream, 2.5% for the Treatment of Actinic Keratoses
U.S. Food and Drug Administration Approves Subcutaneous Formulation of Orencia (abatacept), a Proven Non-Anti-TNF Biologic for Adults with Moderate to Severe Rheumatoid Arthritis
FDA Approves Xarelto (rivaroxaban) to Prevent Stroke in People With Common Type of Abnormal Heart Rhythm
August
FDA Approves Anascorp (antivenom (centruroides scorpion)) - First Specific Treatment for Scorpion Stings
U.S. Food and Drug Administration Approves Gilead Sciences' Complera (emtricitabine, rilpivirine and tenofovir disoproxil fumarate), a New Complete Once-Daily, Single-Tablet Regimen for HIV-1 Infection in Treatment-Naïve Adults
Intersect ENT Announces U.S. Food and Drug Administration Approval for Propel - First Drug Releasing Implant for Chronic Sinusitis Patients
FDA Approves Zelboraf (vemurafenib) and Companion Diagnostic Test for Late-Stage Skin Cancer
FDA Approves Adcetris (brentuximab vedotin) to Treat Two Types of Lymphoma
FDA Approves Shire's Firazyr (icatibant injection) for Acute Attacks of Hereditary Angioedema (HAE)
Nucynta ER (Tapentadol Extended-Release Tablets) Receives FDA Approval for the Management of Moderate to Severe Chronic Pain
FDA Approves Xalkori (crizotinib) with Companion Diagnostic for a Type of Late-Stage Lung Cancer
Seattle Genetics Announces Updates to Adcetris (brentuximab vedotin) Prescribing Information
September
FDA Approves New Indications for Prolia (denosumab) for the Treatment of Bone Loss in Patients With Prostate or Breast Cancer Undergoing Hormone Ablation Therapy
October
FDA Approves Cialis (tadalafil) to Treat Benign Prostatic Hyperplasia
FDA Approves Combination Therapy Juvisync (simvastatin and sitagliptin)
FDA Approves Combivent Respimat (ipratropium bromide and albuterol) Inhalation Spray for the Treatment of Patients with Chronic Obstructive Pulmonary Disease
FDA Approves
Ferriprox (deferiprone) to Treat Patients with Excess Iron in the Body
Byetta (exenatide) Approved for Use with Insulin Glargine in the U.S.
FDA Approves Onfi (clobazam) for Seizures Associated with Lennox-Gastaut Syndrome
Pacira Pharmaceuticals, Inc. Announces U.S. FDA Approval of Exparel (bupivacaine) For Postsurgical Pain Management
Soliris (eculizumab) Approved by FDA for All Patients with Atypical Hemolytic Uremic Syndrome (aHUS)
November
FDA Approves Xarelto (rivaroxaban) to Prevent Stroke in People With Common Type of Abnormal Heart Rhythm
FDA Approves
Erbitux (cetuximab) to Treat Late-stage Head and Neck Cancer
IntelGenx Announces FDA Approval of its High Dose Anti-Depressant Forfivo XL (bupropion hydrochloride)
FDA Approves
Jakafi (ruxolitinib) to Treat Myelofibrosis
Asparaginase
FDA Approves Erwinaze (asparaginase Erwinia chrysanthemi) to Treat Acute Lymphoblastic Leukemia
Aflibercept
FDA Approves Eylea (aflibercept) for Wet Age-Related Macular Degeneration
FDA Approves Intermezzo (zolpidem tartrate) for Middle-of-the-Night Waking Followed by Difficulty Returning to Sleep
FDA Approves Remicade (infliximab) to Treat Ulcerative Colitis in Children Older than 6 Years
December
FDA Expands Use of Prevnar 13 Vaccine for People Ages 50 and Older
Anturol (oxybutynin) Approved by FDA for the Treatment of Overactive Bladder
Endo Announces FDA Approval of a New Formulation of Opana (oxymorphone) ER Designed to be Crush-Resistant
FDA Approves Edarbyclor (azilsartan medoxomil and chlorthalidone) for the Treatment of Hypertension
FDA Expands Use of HIV Drug Isentress (raltegravir) to Children and Adolescents
Careers
