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FDA Approved Drugs in 2011

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
Etravirine
FDA Approves New Dosage Strength for Intelence (etravirine)
Fentanyl Sublingual Tablets
FDA Approval for Abstral (Fentanyl) Sublingual Tablets
Ioflupane I 123
FDA Approves DaTscan (Ioflupane I 123 Injection) for Visualization of Dopamine Transporters in Patients with Suspected Parkinsonian Syndromes
Spinosad
FDA Approves Natroba (spinosad) Head Lice Treatment for Children and Adults
Vilazodone Hydrochloride
FDA Approves Viibryd (vilazodone) to Treat Major Depressive Disorder
Rituximab
FDA Approves Rituxan (rituximab) for First-Line Maintenance Use in Follicular Lymphoma
Gabapentin
Depomed Announces US Food and Drug Administration Approval of Gralise (gabapentin) Once-Daily Tablets for Treatment of Post-Herpetic Neuralgia

February
Hydroxy Progesterone
FDA Approves Makena (hydroxyprogesterone caproate) to Reduce Risk of Preterm Birth in At-Risk Pregnant Women
Atazanavir
Reyataz (atazanavir) label revised, adding dosing recommendations for pregnancy and postpartum period
Aripiprazole
Abilify (aripiprazole) Approved for Maintenance Treatment of Bipolar I Disorder as an Adjunct to Either Lithium or Valproate
Azilsartan Medoxomil
FDA Approves Edarbi (azilsartan medoxomil) to Treat High Blood Pressure
Roflumilast
FDA Approves Daliresp (roflumilast) to Treat Chronic Obstructive Pulmonary Disease

March
Rufinamide
FDA Approves Banzel (rufinamide) Oral Suspension, 40 mg/mL
Belimumab
FDA Approves Benlysta (belimumab) to Treat Lupus
Gadobutrol
U.S. FDA Approves Bayer's Gadavist (gadobutrol) Injection for MRI of the Central Nervous System
Zoster Vaccine Live
FDA Expands Indication for Zostavax (zoster vaccine live), Merck's Shingles Vaccine, to Include Adults Ages 50 to 59
Imiquimod
FDA Approves Zyclara (imiquimod) Cream, 3.75% for the Treatment of External Genital Warts
Ipilimumab
FDA Approves Yervoy (ipilimumab) for Late-Stage Melanoma
Nevirapine
FDA Approves Viramune XR (nevirapine) 400 mg extended release tablet
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

April
Vandetanib
FDA Approves Orphan Drug Caprelsa (vandetanib) for Advanced Medullary Thyroid Cancer
Paliperidone
Invega (paliperidone) Approved as Treatment for Schizophrenia in Adolescents
Rituximab
FDA Approves Rituxan (rituximab) to Treat Two Rare Disorders
Meningococcal Conjugate Vaccine
FDA Approves Menactra (meningococcal conjugate vaccine) to Prevent Meningococcal Disease in Infants and Toddlers
Famotidine And Ibuprofen
Horizon Pharma Announces FDA Approval of Duexis (Ibuprofen/Famotidine)
Lamotrigine
FDA Approves Lamictal XR (Lamotrigine) for Conversion to Monotherapy for Treatment of Partial Seizures in Appropriate Patients
Abiraterone acetate
FDA Approves Zytiga (abiraterone) for Late-Stage Prostate Cancer

May
Levoleucovorin
FDA Approves Fusilev (levoleucovorin) for Use in Patients with Colorectal Cancer
Esomeprazole
FDA Approves Nexium I.V. (Esomeprazole Sodium) for the Treatment of Gastroesophageal Reflux Disease (GERD) With Erosive Esophagitis in Pediatric and Adolescent Patients
Linagliptin
FDA Approves Tradjenta (linagliptin) for Type 2 Diabetes
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
Boceprevir
FDA Approves Merck's Victrelis (boceprevir), First-in-Class Oral Hepatitis C Virus (HCV) Protease Inhibitor
Rilpivirine
FDA Approves New HIV Treatment Edurant (rilpivirine)
Sunitinib
FDA Approves Sutent (sunitinib malate) for Rare Type of Pancreatic Cancer
Telaprevir
FDA Approves Incivek (telaprevir) for People with Hepatitis C
Fidaxomicin
FDA Approves Dificid (fidaxomicin) for Clostridium difficile Infection

June
Insulin Lispro
FDA Approves Updates to Lilly's Humalog (insulin lispro injection [rDNA origin]) Label
Ezogabine
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
Belatacept
FDA Approves Nulojix (belatacept) for Kidney Transplant Patients
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
Oxycodone Hydrochloride
Pfizer and Acura Announce FDA Approval of Oxecta (Oxycodone HCl, USP) CII
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
Azficel-T
Fibrocell Science, Inc. Announces FDA Approval for laViv (azficel-T)
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

July
Rivaroxaban
FDA Approves Xarelto (rivaroxaban) to Prevent Deep Vein Thrombosis in Patients Undergoing Knee or Hip Replacement Surgery
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
Ticagrelor
FDA approves blood-thinning drug Brilinta (ticagrelor) to treat acute coronary syndromes
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
Immune globulin intravenous
Baxter Announces FDA Approval of Subcutaneous Route of Administration for Gammagard Liquid (immune globulin infusion (human)) for Patients with Primary Immunodeficiency
Colesevelam Hcl
Once-Daily Welchol (colesevelam HCl) for Oral Suspension Receives FDA Approval To be Mixed With Fruit Juice or Diet Soft Drinks
Imiquimod
FDA Approves Zyclara (imiquimod) Cream, 2.5% for the Treatment of Actinic Keratoses
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
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
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
Mometasone
Intersect ENT Announces U.S. Food and Drug Administration Approval for Propel - First Drug Releasing Implant for Chronic Sinusitis Patients
Vemurafenib Tablet
FDA Approves Zelboraf (vemurafenib) and Companion Diagnostic Test for Late-Stage Skin Cancer
Brentuximab Vedotin
FDA Approves Adcetris (brentuximab vedotin) to Treat Two Types of Lymphoma
Icatibant
FDA Approves Shire's Firazyr (icatibant injection) for Acute Attacks of Hereditary Angioedema (HAE)
Tapentadol
Nucynta ER (Tapentadol Extended-Release Tablets) Receives FDA Approval for the Management of Moderate to Severe Chronic Pain
Crizotinib
FDA Approves Xalkori (crizotinib) with Companion Diagnostic for a Type of Late-Stage Lung Cancer
Brentuximab Vedotin
Seattle Genetics Announces Updates to Adcetris (brentuximab vedotin) Prescribing Information

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
Tadalafil
FDA Approves Cialis (tadalafil) to Treat Benign Prostatic Hyperplasia
Simvastatin And Sitagliptin
FDA Approves Combination Therapy Juvisync (simvastatin and sitagliptin)
Albuterol And Ipratropium
FDA Approves Combivent Respimat (ipratropium bromide and albuterol) Inhalation Spray for the Treatment of Patients with Chronic Obstructive Pulmonary Disease
Deferiprone
FDA Approves Ferriprox (deferiprone) to Treat Patients with Excess Iron in the Body
Exenatide
Byetta (exenatide) Approved for Use with Insulin Glargine in the U.S.
Clobazam
FDA Approves Onfi (clobazam) for Seizures Associated with Lennox-Gastaut Syndrome
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)

November
Rivaroxaban
FDA Approves Xarelto (rivaroxaban) to Prevent Stroke in People With Common Type of Abnormal Heart Rhythm
Cetuximab
FDA Approves Erbitux (cetuximab) to Treat Late-stage Head and Neck Cancer
Bupropion
IntelGenx Announces FDA Approval of its High Dose Anti-Depressant Forfivo XL (bupropion hydrochloride)
Ruxolitinib
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
Zolpidem
FDA Approves Intermezzo (zolpidem tartrate) for Middle-of-the-Night Waking Followed by Difficulty Returning to Sleep
Infliximab
FDA Approves Remicade (infliximab) to Treat Ulcerative Colitis in Children Older than 6 Years

December
Pneumococcal Vaccine Polyvalent
FDA Expands Use of Prevnar 13 Vaccine for People Ages 50 and Older
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
Azilsartan Medoxomil And Chlorthalidone
FDA Approves Edarbyclor (azilsartan medoxomil and chlorthalidone) for the Treatment of Hypertension
Raltegravir
FDA Expands Use of HIV Drug Isentress (raltegravir) to Children and Adolescents

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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