Comprehensive list of FDA approved drugs by year. Drug information includes the drug name and indication of use.
January
Seattle Genetics Announces Updates to Adcetris (brentuximab vedotin)Prescribing Information
FDA Approves Voraxaze (glucarpidase) to Treat Patients with Toxic Methotrexate Levels
U.S. Food and Drug Administration Approves New Formulations of Viread (tenofovir disoproxil fumarate) for Use by Children Living With HIV
FDA Approves Subcutaneous Administration of Velcade (bortezomib) In All Approved Indications
FDA Approves Zetonna (ciclesonide) Nasal Aerosol for Allergic Rhinitis
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
UCB Announces FDA Approval for Keppra (levetiracetam) in Infants and Children from One Month of Age with Partial Onset Seizures
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
FDA Approves Inlyta (axitinib) for Advanced Renal Cell Carcinoma
FDA Approves Bydureon (exenatide) - The First and Only Once-Weekly Treatment for Type 2 Diabetes
FDA Approves Erivedge (vismodegib) for Basal Cell Carcinoma
FDA Approves Kalydeco (ivacaftor) to Treat Rare Form of Cystic Fibrosis
FDA Approves Gleevec (imatinib mesylate) for Expanded Use in Patients with Rare Gastrointestinal Cancer
FDA Approves Jentadueto (linagliptin/metformin hydrochloride) for the Treatment of Adult Patients with Type 2 Diabetes
February
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
Vyvanse (lisdexamfetamine dimesylate) Capsules, (CII) Now Approved in the US for Maintenance Treatment in Adults with ADHD
Sanofi Announces FDA Approval of Sklice (ivermectin)Lotion for the Treatment of Head Lice
Mobius Therapeutics Receives Final FDA Approval for New Glaucoma Drug
Mitosol (mitomycin)
FDA Approves Zioptan (tafluprost ophthalmic solution), Merck's Once-Daily, Preservative-Free Ophthalmic Medication
FDA Approves Korlym (mifepristone) for Patients with Endogenous Cushing's Syndrome
U.S. FDA Approves Lower Dose Formulation of Angeliq (drospirenone and estradiol) Tablets
March
FDA Approves FluMist (Influenza Virus Vaccine, Live, Intranasal) to Prevent Seasonal Influenza
Pancrelipase
Aptalis Pharma Announces FDA Approval of Ultresa (Pancrelipase) Delayed Release Capsules
Discovery Labs Announces FDA Approval of Surfaxin (lucinactant) for Prevention of Respiratory Distress Syndrome
U.S. FDA Approves Natazia (dienogest and estradiol valerate) First and Only Oral Contraceptive Demonstrated to Treat Heavy Menstrual Bleeding (HMB)
FDA Approves Binosto(alendronate), First and Only Effervescent Osteoporosis Treatment in a Buffered Solution
Teva Announces FDA Approval of QNASL (beclomethasone dipropionate), a New Nonaqueous Nasal Aerosol, for the Treatment of Allergic Rhinitis
FDA Approves Intelence (etravirine) Tablets for Treatment-Experienced Pediatric Patients with HIV-1, Following Priority Review
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
April
FDA Approves Levemir ( Insulin Detemir) Pregnancy Category Change for Women with Diabetes
Neupro (Rotigotine )Approved by U.S. FDA for Parkinson's Disease and Restless Legs Syndrome
FDA Approves Amyvid (Florbetapir F 18 Injection) for Use in Patients Being Evaluated for Alzheimer's Disease and Other Causes of Cognitive Decline
Victoza (Liraglutide) Label Updated to Include Data Showing Superior Efficacy When Compared to Januvia
Novartis drug Afinitor ( Everolimus) approved by FDA as first medication to treat patients with non-cancerous kidney tumors associated with TSC
FDA Approves Votrient ( Pazopanib) for Advanced Soft Tissue Sarcoma
FDA Approves Stendra ( Avanafil) for Erectile Dysfunction
FDA Approves Levaquin (Levofloxacin) as an Antibacterial Treatment for Plague
May
FDA Approves New Orphan Drug Elelyso (Taliglucerase alfa) to Treat a Form of Gaucher Disease
MEDA Announces Dymista (Azelastine and Fluticasone) Approved by the FDA for Allergic Rhinitis
Fabior (tazarotene) FDA Approval History for acne
Pancrelipase
Digestive Care, Inc. Announces FDA Approval of Pertzye (pancrelipase) Delayed-Release Capsules
FDA Approves Levemir ( Insulin Detemir) for Expanded Use in Children Two to Five Years of Age with Type 1 Diabetes
June
GSK and XenoPort Receive FDA Approval for Horizant for Postherpetic Neuralgia
FDA Approves Perjeta (pertuzumab) for People With HER2-Positive Metastatic Breast Cancer
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
FDA Approves Lyrica (Pregabalin) For The Management Of Neuropathic Pain Associated With Spinal Cord Injury Based On Priority Review
Immune Globulin Infusion (Human)
Baxter Announces FDA Approval for Gammagard Liquid ( immune globulin infusion (human)) as a Treatment for Multifocal Motor Neuropathy
FDA Approves Belviq (Lorcaserin) to Treat Some Overweight or Obese Adults
July
FDA Approves Truvada for Reducing the Risk of Sexually Acquired HIV Infection
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
FDA Approves Truvada (emtricitabine and tenofovir) for Reducing the Risk of Sexually Acquired HIV Infection
Sodium Picosulfate, Magnesium Oxide And Citric Acid
FDA Approves Prepopik(sodium picosulfate, magnesium oxide and citric acid) for Oral Solution for Colonoscopy Prep
Phentermine And Topiramate
FDA Approves Weight-Management Drug Qsymia (phentermine and topiramate)
FDA Approves Kyprolis (carfilzomib) for Patients with Advanced Multiple Myeloma
FDA Approves Afinitor (everolimus) for Advanced Breast Cancer
FDA Approves Tudorza (aclidinium bromide) Pressair to Treat Chronic Obstructive Pulmonary Disease
Amarin Announces FDA Approval of Vascepa (icosapent ethyl) Capsules for the Reduction of Triglyceride Levels in Adult Patients With Severe Hypertriglyceridemia
Horizon Pharma Announces FDA Approval of Rayos (prednisone) Delayed-Release Tablets for Rheumatoid Arthritis and Multiple Additional Indications
August
FDA Approves Zaltrap (ziv-aflibercept) for Metastatic Colorectal Cancer
Vincristine Sulfate Liposomes
FDA Approves Marqibo (vincristine sulfate liposomes) for Philadelphia Chromosome Negative Acute Lymphoblastic Leukemia
FDA Approves Lucentis (ranibizumab injection) for Treatment of Diabetic Macular Edema (DME)
Sanofi Announces FDA Approval for Auvi-Q(epinephrine), First Voice-guided Epinephrine Auto-injector for Patients with Life-threatening Allergies
FDA approves updated prescribing information for Tradjenta (linagliptin) tablets for add-on therapy to insulin in adults with type 2 diabetes
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
FDA Approves Mallinckrodt's Exalgo (hydromorphone HCl) Extended-Release Tablets 32 mg (CII) for Opioid-Tolerant Patients with Moderate-to-Severe Chronic Pain
FDA Approves New Combination Pill Stribild (cobicistat, elvitegravir, emtricitabine and tenofovir)for HIV Treatment
FDA Approves Nucynta ER (tapentadol) Extended-Release Oral Tablets for the Management of Neuropathic Pain Associated With Diabetic Peripheral Neuropathy
FDA Approves Afinitor Disperz (everolimus)- First Drug Formulated for Children with Rare Brain Tumor
Tbo-Filgrastim
FDA Approves Tbo-filgrastim for Severe Neutropenia in Certain Cancer Patients
FDA Approves Linzess (linaclotide)to Treat Certain Cases of Irritable Bowel Syndrome and Constipation
FDA Approves Xtandi (enzalutamide)for Late-Stage Castration-Resistant Prostate Cancer
September
Higher Dose of Novartis Drug Exelon (rivastigmine) Patch Approved By FDA for Patients With Mild to Moderate Alzheimer's Disease
FDA Approves Bosulif (bosutinib)for Chronic Myelogenous Leukemia
FDA Approves New Multiple Sclerosis Treatment Aubagio (teriflunomide)
FDA Approves New Indication For Prolia (Denosumab) For The Treatment Of Bone Loss In Men With Osteoporosis At High Risk For Fracture
FDA Approves Stivarga (regorafenib) for Advanced Colorectal Cancer
FDA Approves Humira (adalimumab) to Treat Ulcerative Colitis
NextWave Pharmaceuticals Receives FDA Approval of Quillivant XR(methylphenidate) for Once-Daily Treatment of ADHD
October
Sigma-Tau Pharmaceuticals, Inc. Receives FDA Approval of Cystaran (cysteamine ophthalmic solution) 0.44%
Paclitaxel Protein-Bound
FDA Approves Abraxane (paclitaxel protein-bound) for the First-Line Treatment of Advanced Non-Small Cell Lung Cancer
FDA Approves Jetrea (ocriplasmin) for Symptomatic Vitreomacular Adhesion in the Eyes
FDA Approves Fycompa (perampanel) to Treat Seizures
FDA Approves Synribo (omacetaxine mepesuccinate) for Chronic Myelogenous Leukemia
November
FDA Expands Use of Xarelto (rivaroxaban) to Treat, Reduce Recurrence of Blood Clots
FDA Approves Xeljanz (tofacitinib) for Rheumatoid Arthritis
FDA has approved Promacta (eltrobopag) for the treatment of thrombocytopenia (low blood platelet counts) in patients with chronic hepatitis C
FDA Approves Flucelvax (influenza virus vaccine) - First Seasonal Influenza Vaccine Manufactured Using Cell Culture Technology
FDA Approves Cometriq (cabozantinib) to Treat Rare Type of Thyroid Cancer
December
FDA has approved Evarrest (Fibrin Sealant Patch), a novel product that rapidly and reliably aids in stopping problematic bleeding during surgery.
FDA Expands Zytiga’s Use for Late-Stage Prostate Cancer
FDA Approves Iclusig (ponatinib) to Treat Two Rare Types of Leukemia
FDA Approves Raxibacumab to Treat Inhalational Anthrax
Pasireotide
FDA Approves Signifor (pasireotide), a New Orphan Drug for Cushing’s Disease
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.
FDA Approves Adasuve (loxapine) Inhalation Powder for the Acute Treatment of Agitation Associated with Schizophrenia or Bipolar I Disorder in Adults
FDA Approves Biotest's Bivigam, an Intravenous Immune Globulin (Human), 10% Liquid
FDA Expands Tamiflu's (oseltamivir) Use to Treat Children Younger Than One Year
FDA Approves Gattex(teduglutide) to Treat Short Bowel Syndrome
Varicella Zoster Immune Globulin
FDA Approves Varizig (varicella zoster immune globulin) for Reducing Chickenpox Symptoms
FDA Approves Juxtapid (lomitapide) - New Orphan Drug for Rare Cholesterol Disorder
FDA Approves Eliquis (apixaban) to Reduce the Risk of Stroke, Blood Clots in Patients with Non-Valvular Atrial Fibrillation
FDA Approves Sirturo (bedaquiline) to Treat Multi-Drug Resistant Tuberculosis
FDA Approves Fulyzaq (crofelemer) - First Anti-Diarrheal Drug for HIV/AIDS Patients
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