Browse the FDA Approved Drugs by Year
Browse 2011 FDA Approved Drugs by Month
Gabapentin
Depomed Announces US Food and Drug Administration Approval of Gralise (gabapentin) Once-Daily Tablets for Treatment of Post-Herpetic Neuralgia
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Ioflupane I 123
FDA Approves DaTscan (Ioflupane I 123 Injection) for Visualization of Dopamine Transporters in Patients with Suspected Parkinsonian Syndromes
February
Aripiprazole
Abilify (aripiprazole) Approved for Maintenance Treatment of Bipolar I Disorder as an Adjunct to Either Lithium or Valproate
Atazanavir
Reyataz (atazanavir) label revised, adding dosing recommendations for pregnancy and postpartum period
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Hydroxy Progesterone
FDA Approves Makena (hydroxyprogesterone caproate) to Reduce Risk of Preterm Birth in At-Risk Pregnant Women
Gadobutrol
U.S. FDA Approves Bayer's Gadavist (gadobutrol) Injection for MRI of the Central Nervous System
Peginterferon Alfa 2 B
FDA Approves Merck's Sylatron (peginterferon alfa-2b) for Injection, a New Adjuvant Treatment for Melanoma with Microscopic or Gross Nodal Involvement
Zoster Vaccine Live
FDA Expands Indication for Zostavax (zoster vaccine live), Merck's Shingles Vaccine, to Include Adults Ages 50 to 59
Lamotrigine
FDA Approves Lamictal XR (Lamotrigine) for Conversion to Monotherapy for Treatment of Partial Seizures in Appropriate Patients
Meningococcal Conjugate Vaccine
FDA Approves Menactra (meningococcal conjugate vaccine) to Prevent Meningococcal Disease in Infants and Toddlers
Paliperidone
Invega (paliperidone) Approved as Treatment for Schizophrenia in Adolescents
May
Boceprevir
FDA Approves Merck's Victrelis (boceprevir), First-in-Class Oral Hepatitis C Virus (HCV) Protease Inhibitor
Esomeprazole
FDA Approves Nexium I.V. (Esomeprazole Sodium) for the Treatment of Gastroesophageal Reflux Disease (GERD) With Erosive Esophagitis in Pediatric and Adolescent Patients
Everolimus
Novartis Gains FDA Approval for Afinitor (everolimus) As First New Treatment in Nearly Three Decades for Patients With Advanced Pancreatic NET
Influenza Virus Vaccine
FDA Licenses Fluzone (influenza virus vaccine, inactivated) Intradermal - Sanofi Pasteur's New Influenza Vaccine Delivered by Intradermal Microinjection
Chlorpheniramine- Hydrocodone- Pseudoephedrine
FDA Approves Zutripro (hydrocodone bitartrate, chlorpheniramine maleate and pseudoephedrine HCl) Oral Solution
Hydrocodone And Pseudoephedrine
FDA Approves Rezira (hydrocodone bitartrate and pseudoephedrine HCl) Oral Solution
Insulin Lispro
FDA Approves Updates to Lilly's Humalog (insulin lispro injection [rDNA origin]) Label
Leuprolide
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
Nitroglycerin Ointment
ProStrakan Receives FDA Approval for Rectiv (nitroglycerin) for the Treatment of Moderate to Severe Pain Associated With Chronic Anal Fissures
Pancrelipase
Abbott Receives FDA Approval for Creon (pancrelipase) Infant-Specific Dosage for Patients With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis
Romidepsin
FDA Grants Accelerated Approval of Istodax (romidepsin) As Treatment for Patients with Peripheral T-Cell Lymphoma Who Have Received at Least One Prior Therapy
July
Abatacept
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
Colesevelam Hcl
Once-Daily Welchol (colesevelam HCl) for Oral Suspension Receives FDA Approval To be Mixed With Fruit Juice or Diet Soft Drinks
Immune globulin intravenous
Baxter Announces FDA Approval of Subcutaneous Route of Administration for Gammagard Liquid (immune globulin infusion (human)) for Patients with Primary Immunodeficiency
Incobotulinumtoxina
Merz Aesthetics Announces FDA Approval Of Xeomin (incobotulinumtoxinA) For The Temporary Improvement In The Appearance Of Moderate To Severe Glabellar Lines In Adult Patients
Indacaterol
FDA Approves Arcapta (indacaterol) Neohaler to treat Chronic Obstructive Pulmonary Disease
Mesalamine(Mesalazine)
Lialda (Mesalamine) Now Approved in U.S. for Maintenance of Remission of Ulcerative Colitis
Rivaroxaban
FDA Approves Xarelto (rivaroxaban) to Prevent Deep Vein Thrombosis in Patients Undergoing Knee or Hip Replacement Surgery
Rivaroxaban
FDA Approves Xarelto (rivaroxaban) to Prevent Stroke in People With Common Type of Abnormal Heart Rhythm
August
Antivenom
FDA Approves Anascorp (antivenom (centruroides scorpion)) - First Specific Treatment for Scorpion Stings
Brentuximab Vedotin
Seattle Genetics Announces Updates to Adcetris (brentuximab vedotin) Prescribing Information
Crizotinib
FDA Approves Xalkori (crizotinib) with Companion Diagnostic for a Type of Late-Stage Lung Cancer
Emtricitabine- Rilpivirine- Tenofovir
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
Icatibant
FDA Approves Shire's Firazyr (icatibant injection) for Acute Attacks of Hereditary Angioedema (HAE)
Mometasone
Intersect ENT Announces U.S. Food and Drug Administration Approval for Propel - First Drug Releasing Implant for Chronic Sinusitis Patients
Tapentadol
Nucynta ER (Tapentadol Extended-Release Tablets) Receives FDA Approval for the Management of Moderate to Severe Chronic Pain
Vemurafenib Tablet
FDA Approves Zelboraf (vemurafenib) and Companion Diagnostic Test for Late-Stage Skin Cancer
September
Denosumab
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
Albuterol And Ipratropium
FDA Approves Combivent Respimat (ipratropium bromide and albuterol) Inhalation Spray for the Treatment of Patients with Chronic Obstructive Pulmonary Disease
Bupivacaine
Pacira Pharmaceuticals, Inc. Announces U.S. FDA Approval of Exparel (bupivacaine) For Postsurgical Pain Management
Eculizumab
Soliris (eculizumab) Approved by FDA for All Patients with Atypical Hemolytic Uremic Syndrome (aHUS)
Asparaginase
FDA Approves Erwinaze (asparaginase Erwinia chrysanthemi) to Treat Acute Lymphoblastic Leukemia
Bupropion
IntelGenx Announces FDA Approval of its High Dose Anti-Depressant Forfivo XL (bupropion hydrochloride)
Infliximab
FDA Approves Remicade (infliximab) to Treat Ulcerative Colitis in Children Older than 6 Years
Rivaroxaban
FDA Approves Xarelto (rivaroxaban) to Prevent Stroke in People With Common Type of Abnormal Heart Rhythm
Zolpidem
FDA Approves Intermezzo (zolpidem tartrate) for Middle-of-the-Night Waking Followed by Difficulty Returning to Sleep
December
Azilsartan Medoxomil And Chlorthalidone
FDA Approves Edarbyclor (azilsartan medoxomil and chlorthalidone) for the Treatment of Hypertension
Oxybutynin Hydrochloride
Anturol (oxybutynin) Approved by FDA for the Treatment of Overactive Bladder
Oxymorphone
Endo Announces FDA Approval of a New Formulation of Opana (oxymorphone) ER Designed to be Crush-Resistant
