| January | February | March | April |
| May | June | July | August |
| September | October | November | December |
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Etravirine
FDA Approves New Dosage Strength for Intelence (etravirine) |
Fentanyl Sublingual Tablets
FDA Approval for Abstral (Fentanyl) Sublingual Tablets |
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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 |
Spinosad
FDA Approves Natroba (spinosad) Head Lice Treatment for Children and Adults |
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Vilazodone Hydrochloride
FDA Approves Viibryd (vilazodone) to Treat Major Depressive Disorder |
Rituximab
FDA Approves Rituxan (rituximab) for First-Line Maintenance Use in Follicular Lymphoma |
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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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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 |
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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 |
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Roflumilast
FDA Approves Daliresp (roflumilast) to Treat Chronic Obstructive Pulmonary Disease |
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Rufinamide
FDA Approves Banzel (rufinamide) Oral Suspension, 40 mg/mL |
Belimumab
FDA Approves Benlysta (belimumab) to Treat Lupus |
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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 |
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Imiquimod
FDA Approves Zyclara (imiquimod) Cream, 3.75% for the Treatment of External Genital Warts |
Ipilimumab
FDA Approves Yervoy (ipilimumab) for Late-Stage Melanoma |
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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 |
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Vandetanib
FDA Approves Orphan Drug Caprelsa (vandetanib) for Advanced Medullary Thyroid Cancer |
Paliperidone
Invega (paliperidone) Approved as Treatment for Schizophrenia in Adolescents |
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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 |
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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 |
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Abiraterone acetate
FDA Approves Zytiga (abiraterone) for Late-Stage Prostate Cancer |
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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 |
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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 |
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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 |
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Rilpivirine
FDA Approves New HIV Treatment Edurant (rilpivirine) |
Sunitinib
FDA Approves Sutent (sunitinib malate) for Rare Type of Pancreatic Cancer |
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Telaprevir
FDA Approves Incivek (telaprevir) for People with Hepatitis C |
Fidaxomicin
FDA Approves Dificid (fidaxomicin) for Clostridium difficile Infection |
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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) |
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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 |
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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 |
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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 |
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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 |
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Hydrocodone And Pseudoephedrine
FDA Approves Rezira (hydrocodone bitartrate and pseudoephedrine HCl) Oral Solution |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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) |
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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 |
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Brentuximab Vedotin
Seattle Genetics Announces Updates to Adcetris (brentuximab vedotin) Prescribing Information |
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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 |
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Tadalafil
FDA Approves Cialis (tadalafil) to Treat Benign Prostatic Hyperplasia |
Simvastatin And Sitagliptin
FDA Approves Combination Therapy Juvisync (simvastatin and sitagliptin) |
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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 |
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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 |
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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) |
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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 |
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Bupropion
IntelGenx Announces FDA Approval of its High Dose Anti-Depressant Forfivo XL (bupropion hydrochloride) |
Ruxolitinib
FDA Approves Jakafi (ruxolitinib) to Treat Myelofibrosis |
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Asparaginase
FDA Approves Erwinaze (asparaginase Erwinia chrysanthemi) to Treat Acute Lymphoblastic Leukemia |
Aflibercept
FDA Approves Eylea (aflibercept) for Wet Age-Related Macular Degeneration |
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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 |
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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 |
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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 |
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Raltegravir
FDA Expands Use of HIV Drug Isentress (raltegravir) to Children and Adolescents |