Browse the FDA Approved Drugs by Year
Browse 2012 FDA Approved Drugs by Month
Bortezomib
FDA Approves Subcutaneous Administration of Velcade (bortezomib) In All Approved Indications
Brentuximab Vedotin
Seattle Genetics Announces Updates to Adcetris (brentuximab vedotin)Prescribing Information
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Exenatide
FDA Approves Bydureon (exenatide) - The First and Only Once-Weekly Treatment for Type 2 Diabetes
Ezetimibe and simvastatin
New FDA Approved Labeling For Vytorin (ezetimibe/simvastatin) Includes Results From the Study of Heart and Renal Protection (SHARP) in Patients With Moderate to Severe Chronic Kidney Disease
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Glucarpidase Injection
FDA Approves Voraxaze (glucarpidase) to Treat Patients with Toxic Methotrexate Levels
Imatinib
FDA Approves Gleevec (imatinib mesylate) for Expanded Use in Patients with Rare Gastrointestinal Cancer
Ingenol Mebutate Topical Gel
FDA Approves Picato (ingenol mebutate) Gel, the First and Only Topical Actinic Keratosis (AK) Therapy With 2 or 3 Consecutive Days of Once-Daily Dosing
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Levetiracetam
UCB Announces FDA Approval for Keppra (levetiracetam) in Infants and Children from One Month of Age with Partial Onset Seizures
Linagliptin And Metformin Hydrochloride
FDA Approves Jentadueto (linagliptin/metformin hydrochloride) for the Treatment of Adult Patients with Type 2 Diabetes
Tenofovir
U.S. Food and Drug Administration Approves New Formulations of Viread (tenofovir disoproxil fumarate) for Use by Children Living With HIV
February
Drospirenone And Estradiol
U.S. FDA Approves Lower Dose Formulation of Angeliq (drospirenone and estradiol) Tablets
Ivermectin
Sanofi Announces FDA Approval of Sklice (ivermectin)Lotion for the Treatment of Head Lice
Lisdexamfetamine
Vyvanse (lisdexamfetamine dimesylate) Capsules, (CII) Now Approved in the US for Maintenance Treatment in Adults with ADHD
Sitagliptin-Metformin
FDA Approves Janumet XR (sitagliptin and metformin HCl extended-release) for Type 2 Diabetes, Offering the Powerful Efficacy of Janumet (sitagliptin/metformin HCl) Now Available with Once-Daily Convenience
Tafluprost
FDA Approves Zioptan (tafluprost ophthalmic solution), Merck's Once-Daily, Preservative-Free Ophthalmic Medication
March
Alendronate
FDA Approves Binosto(alendronate), First and Only Effervescent Osteoporosis Treatment in a Buffered Solution
Beclomethasone Dipropionate
Teva Announces FDA Approval of QNASL (beclomethasone dipropionate), a New Nonaqueous Nasal Aerosol, for the Treatment of Allergic Rhinitis
Dienogest And Estradiol Valerate
U.S. FDA Approves Natazia (dienogest and estradiol valerate) First and Only Oral Contraceptive Demonstrated to Treat Heavy Menstrual Bleeding (HMB)
Etravirine
FDA Approves Intelence (etravirine) Tablets for Treatment-Experienced Pediatric Patients with HIV-1, Following Priority Review
Influenza Virus Vaccine
FDA Approves FluMist (Influenza Virus Vaccine, Live, Intranasal) to Prevent Seasonal Influenza
Lucinactant
Discovery Labs Announces FDA Approval of Surfaxin (lucinactant) for Prevention of Respiratory Distress Syndrome
Pancrelipase
Aptalis Pharma Announces FDA Approval of Ultresa (Pancrelipase) Delayed Release Capsules
Peginesatide
Affymax and Takeda Announce FDA Approval of Omontys (peginesatide) Injection for the Treatment of Anemia Due to Chronic Kidney Disease (CKD) in Adult Patients on Dialysis
Everolimus
Novartis drug Afinitor ( Everolimus) approved by FDA as first medication to treat patients with non-cancerous kidney tumors associated with TSC
Florbetapir F 18
FDA Approves Amyvid (Florbetapir F 18 Injection) for Use in Patients Being Evaluated for Alzheimer's Disease and Other Causes of Cognitive Decline
Insulin Detemir
FDA Approves Levemir ( Insulin Detemir) Pregnancy Category Change for Women with Diabetes
Liraglutide [rDNA] Injection
Victoza (Liraglutide) Label Updated to Include Data Showing Superior Efficacy When Compared to Januvia
Rotigotine
Neupro (Rotigotine )Approved by U.S. FDA for Parkinson's Disease and Restless Legs Syndrome
May
Azelastine And Fluticasone
MEDA Announces Dymista (Azelastine and Fluticasone) Approved by the FDA for Allergic Rhinitis
Insulin Detemir
FDA Approves Levemir ( Insulin Detemir) for Expanded Use in Children Two to Five Years of Age with Type 1 Diabetes
Pancrelipase
Digestive Care, Inc. Announces FDA Approval of Pertzye (pancrelipase) Delayed-Release Capsules
Taliglucerase Alfa
FDA Approves New Orphan Drug Elelyso (Taliglucerase alfa) to Treat a Form of Gaucher Disease
June
Gabapentin Enacarbil
GSK and XenoPort Receive FDA Approval for Horizant for Postherpetic Neuralgia
Immune Globulin Infusion (Human)
Baxter Announces FDA Approval for Gammagard Liquid ( immune globulin infusion (human)) as a Treatment for Multifocal Motor Neuropathy
Meningococcal Groups C And Y And Haemophilus B Tetanus Toxoid Conjugate Vaccine
MenHibrix (Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine) FDA Approval History
Pregabalin
FDA Approves Lyrica (Pregabalin) For The Management Of Neuropathic Pain Associated With Spinal Cord Injury Based On Priority Review
July
Aclidinium Bromide Oral Inhalation
FDA Approves Tudorza (aclidinium bromide) Pressair to Treat Chronic Obstructive Pulmonary Disease
Emtricitabine- Tenofovir
FDA Approves Truvada for Reducing the Risk of Sexually Acquired HIV Infection
Emtricitabine- Tenofovir
FDA Approves Truvada (emtricitabine and tenofovir) for Reducing the Risk of Sexually Acquired HIV Infection
Icosapent Ethyl
Amarin Announces FDA Approval of Vascepa (icosapent ethyl) Capsules for the Reduction of Triglyceride Levels in Adult Patients With Severe Hypertriglyceridemia
Phentermine And Topiramate
FDA Approves Weight-Management Drug Qsymia (phentermine and topiramate)
Prednisone
Horizon Pharma Announces FDA Approval of Rayos (prednisone) Delayed-Release Tablets for Rheumatoid Arthritis and Multiple Additional Indications
Sodium Picosulfate, Magnesium Oxide And Citric Acid
FDA Approves Prepopik(sodium picosulfate, magnesium oxide and citric acid) for Oral Solution for Colonoscopy Prep
Sodium Picosulfate, Magnesium Oxide And Citric Acid) For Oral Solution
FDA Approves Prepopik ( sodium picosulfate, magnesium oxide and citric acid) for Oral Solution )for Colonoscopy Prep
August
Buprenorphine And Naloxone
Reckitt Benckiser Pharmaceuticals Inc. Announces FDA Approval of Two New Dosage Strengths of Suboxone (buprenorphine and naloxone) Sublingual Film (C-III) for Maintenance Treatment of Opioid Dependence
Cobicistat-Elvitegravir-Emtricitabine-Tenofovir
FDA Approves New Combination Pill Stribild (cobicistat, elvitegravir, emtricitabine and tenofovir)for HIV Treatment
Epinephrine
Sanofi Announces FDA Approval for Auvi-Q(epinephrine), First Voice-guided Epinephrine Auto-injector for Patients with Life-threatening Allergies
Everolimus
FDA Approves Afinitor Disperz (everolimus)- First Drug Formulated for Children with Rare Brain Tumor
Hydromorphone
FDA Approves Mallinckrodt's Exalgo (hydromorphone HCl) Extended-Release Tablets 32 mg (CII) for Opioid-Tolerant Patients with Moderate-to-Severe Chronic Pain
Linaclotide
FDA Approves Linzess (linaclotide)to Treat Certain Cases of Irritable Bowel Syndrome and Constipation
Linagliptin
FDA approves updated prescribing information for Tradjenta (linagliptin) tablets for add-on therapy to insulin in adults with type 2 diabetes
Ranibizumab
FDA Approves Lucentis (ranibizumab injection) for Treatment of Diabetic Macular Edema (DME)
Tapentadol
FDA Approves Nucynta ER (tapentadol) Extended-Release Oral Tablets for the Management of Neuropathic Pain Associated With Diabetic Peripheral Neuropathy
Tbo-Filgrastim
FDA Approves Tbo-filgrastim for Severe Neutropenia in Certain Cancer Patients
Vincristine Sulfate Liposomes
FDA Approves Marqibo (vincristine sulfate liposomes) for Philadelphia Chromosome Negative Acute Lymphoblastic Leukemia
Denosumab
FDA Approves New Indication For Prolia (Denosumab) For The Treatment Of Bone Loss In Men With Osteoporosis At High Risk For Fracture
Methylphenidate
NextWave Pharmaceuticals Receives FDA Approval of Quillivant XR(methylphenidate) for Once-Daily Treatment of ADHD
Rivastigmine
Higher Dose of Novartis Drug Exelon (rivastigmine) Patch Approved By FDA for Patients With Mild to Moderate Alzheimer's Disease
October
Cysteamine Ophthalmic Solution
Sigma-Tau Pharmaceuticals, Inc. Receives FDA Approval of Cystaran (cysteamine ophthalmic solution) 0.44%
Omacetaxine Mepesuccinate
FDA Approves Synribo (omacetaxine mepesuccinate) for Chronic Myelogenous Leukemia
Paclitaxel Protein-Bound
FDA Approves Abraxane (paclitaxel protein-bound) for the First-Line Treatment of Advanced Non-Small Cell Lung Cancer
Eltrombopag
FDA has approved Promacta (eltrobopag) for the treatment of thrombocytopenia (low blood platelet counts) in patients with chronic hepatitis C
Influenza Virus Vaccine
FDA Approves Flucelvax (influenza virus vaccine) - First Seasonal Influenza Vaccine Manufactured Using Cell Culture Technology
Apixaban
FDA Approves Eliquis (apixaban) to Reduce the Risk of Stroke, Blood Clots in Patients with Non-Valvular Atrial Fibrillation
Fibrin Sealant (Human)
FDA has approved Evarrest (Fibrin Sealant Patch), a novel product that rapidly and reliably aids in stopping problematic bleeding during surgery.Â
Immune Globulin Intravenous
FDA Approves Biotest's Bivigam, an Intravenous Immune Globulin (Human), 10% Liquid
Influenza Virus Vaccine, Inactivated
FDA Approves GlaxoSmithKline's Fluarix Quadrivalent (influenza virus vaccine, inactivated) - Four-strain Seasonal Influenza Vaccine for Use in the U.S.
Loxapine
FDA Approves Adasuve (loxapine) Inhalation Powder for the Acute Treatment of Agitation Associated with Schizophrenia or Bipolar I Disorder in Adults
Varicella Zoster Immune Globulin
FDA Approves Varizig (varicella zoster immune globulin) for Reducing Chickenpox Symptoms