Comprehensive list of FDA approved drugs by year. Drug information includes the drug name and indication of use.
January
Collegium Pharmaceutical Announces FDA Approval of AllerNaze (triamcinolone acetonide), a Nasal Inhaled Steroid for the Treatment of Allergic Rhinitis
Anesiva Announces FDA Approval of sNDA to Expand Zingo (lidocaine hydrochloride monohydrate) Indication to Include Adults
Forest and Cypress Announce FDA Approval of
Savella (milnacipran) for the Management of Fibromyalgia
CSL Behring Receives FDA Approval of RiaSTAP (Fibrinogen Concentrate (Human)) , First and Only Approved Treatment of Acute Bleeding Episodes in Patients with Congenital Fibrinogen Deficiency
Watson's Gelnique (oxybutynin chloride) Gel 10% Approved by FDA for the Treatment of Overactive Bladder
FDA Approves Kapidex (dexlansoprazole) for the Treatment of GERD
Galderma Wins FDA Approval for Vectical Ointment, a Novel Topical Therapy for Mild-to-Moderate Plaque Psoriasis
HIV/AIDS Update - Traditional Approval of Isentress (raltegravir)
February
United States Food and Drug Administration (FDA) Approves IV Formulation of Temodar (temozolomide)
ATryn (Antithrombin [Recombinant]) Approved by the FDA
FDA Approves Uloric (febuxostat) for the Chronic Management of Hyperuricemia in Patients with Gout
FDA Approves Symbicort (budesonide and formoterol) for Chronic Obstructive Pulmonary Disease (COPD)
March
Orexo's Edluar (zolpidem) receives FDA approval for the treatment of insomnia
Forest Laboratories, Inc. Announces FDA Approval of
Lexapro (escitalopram oxalate) for the Treatment of Major Depressive Disorder in Adolescents
FDA Approves Symbyax (fluoxetine and olanzapine) as First Medication for Treatment-Resistant Depression
FDA Approves New Indication for Wyeth's Tygacil (tigecycline) for the Treatment of Adult Patients with Community-Acquired Bacterial Pneumonia
Afinitor (everolimus) approved in US as first treatment for patients with advanced kidney cancer after failure of either sunitinib or sorafenib
Intercell Announces FDA Approval of
Ixiaro (Japanese Encephalitis Virus Vaccine, Inactivated, Adsorbed) , a Novel Vaccine to Prevent Japanese Encephalitis
April
Coartem (artemether and lumefantrine) receives FDA approval becoming first artemisinin-based combination treatment (ACT) for malaria in the US
Benzyl Alcohol
Sciele Pharma Announces FDA Approval of Ulesfia (benzyl alcohol) Lotion 5%, First Prescription Non-Neurotoxic Head Lice Treatment
Simponi (golimumab) Receives FDA Approval as First Once-Monthly Anti-TNF for Treatment of Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis
FDA Approves Dysport (abobotulinumtoxinA) for Therapeutic and Aesthetic Uses
FDA approves Exforge HCT (amlodipine, valsartan and hydrochlorothiazide) - the only high blood pressure treatment to combine three medications in a single pill
May
FDA Approves Cetraxal (ciprofloxacin otic) Otic Solution
FDA Grants Accelerated Approval of
Avastin (bevacizumab) for Brain Cancer (Glioblastoma) That Has Progressed Following Prior Therapy
Bromocriptine Mesylate
VeroScience Announces FDA Approval of Cycloset (bromocriptine mesylate) for Treatment of Type 2 Diabetes
FDA Approves Fanapt (iloperidone) to Treat Schizophrenia
FDA Approves Lamictal (lamotrigine) ODT Orally Disintegrating Tablets
Azor (amlodipine and olmesartan) Receives FDA Approval as First-Line Treatment for High Blood Pressure
FDA Approves ACTOplus met XR (pioglitazone HCl and metformin HCl extended-release) Tablets for the Treatment of Type 2 Diabetes
UCB's Cimzia (certolizumab pegol) Approved by the U.S. FDA for Adult Patients Suffering From Moderate to Severe Rheumatoid Arthritis
Novartis Receives Approval From FDA To Market Prevacid (lansoprazole) 24HR As First And Only OTC Proton Pump Inhibitor In Original Prescription Formulation
FDA Grants Approval for Use of Risperdal (risperidone) Consta as Both a Monotherapy and Adjunctive Therapy in the Maintenance Treatment of Bipolar I Disorder
FDA Approves Samsca (tolvaptan), the First and Only Oral Vasopressin Antagonist to Treat Patients With Clinically Significant Hypervolemic and Euvolemic Hyponatremia
FDA Approves Adcirca (tadalafil) Tablets for the Treatment of Pulmonary Arterial Hypertension
FDA Grants Full Approval for Sprycel (dasatinib) for the Treatment of Adults with Chronic Myeloid Leukemia Who Are Resistant or Intolerant to Prior Therapies Including Gleevec
Astellas Receives FDA Approval for Use of Prograf (Tacrolimus) in Conjunction With Mycophenolate Mofetil (MMF) in Kidney Transplant Recipients
Bausch & Lomb Receives FDA Approval of Besivance (besifloxacin), New Topical Ophthalmic Antibacterial for the Treatment of Bacterial Conjunctivitis ('Pink Eye')
June
FDA Approves Reclast (zoledronic acid) to Prevent Osteoporosis in Postmenopausal Women With Convenient Less Frequent Dosing
Cumberland Pharmaceuticals Announces FDA Approval of Caldolor (ibuprofen)
New Biological Therapy
Ilaris (canakinumab) Approved In US To Treat Children And Adults With CAPS, A Serious Life-Long Auto-Inflammatory Disease
Dexamethasone Ophthalmic
Allergan Receives FDA Approval for Ozurdex (dexamethasone) Biodegradable, Injectable Steroid Implant with Extended Drug Release for Retinal Disease
FDA Approves
Cambia (diclofenac potassium)for Migraine
FDA Approves Feraheme (ferumoxytol) to Treat Iron Deficiency Anemia in Adult Chronic Kidney Disease Patients
July
FDA Approves Multaq (dronedarone) for Patients with Atrial Fibrillation or Atrial Flutter
Lilly Receives Fourth FDA Approval for Alimta (pemetrexed for injection) as Maintenance Therapy For Nonsquamous Non-Small Cell Lung Cancer
Daiichi Sankyo and Lilly Receive U.S. FDA Approval for Effient (prasugrel)
FDA Approves Plan B One-Step (levonorgestrel) , a New One-Pill Emergency Contraceptive
BioDelivery Sciences and Meda Announce FDA Approval of Onsolis (fentanyl)
FDA Approves NovoLog (insulin aspart) Labeling Update
FDA Approves
Tekturna HCT (aliskiren and hydrochlorothiazide) as Initial Treatment in Patients Unlikely to Achieve Their Blood Pressure Goals With a Single Agent
Allergan Receives FDA Approval for Acuvail (ketorolac tromethamine) Ophthalmic Solution for the Treatment of Pain and Inflammation Following Cataract Surgery
FDA Approves Expanded Use of Lilly's Forteo [teriparatide (rDNA origin) injection] to Treat Glucocorticoid-Induced Osteoporosis
Injectable Poly-L-Lactic Acid
FDA Approves Sculptra (injectable poly-L-lactic acid) Aesthetic, a Facial Injectable for Correction of Nasolabial Folds and Other Facial Wrinkles
FDA Approves Tyvaso (treprostinil) Inhalation Solution for the Treatment of Pulmonary Arterial Hypertension
FDA Approves Colcrys (colchicine) for Acute Gout, Mediterranean Fever
FDA Approves Onglyza (saxagliptin) for Type 2 Diabetes
The US FDA approves
Lipsovir (acyclovir and hydrocortisone) for marketing and sales in US
FDA Approves Avastin for the Most Common Type of Kidney Cancer
Paliperidone
Invega Approved as the First and Only Treatment for Schizoaffective Disorder
August
FDA Approves Livalo (pitavastatin) for Primary Hypercholesterolemia and Combined Dyslipidemia
FDA Approves Embeda (morphine sulfate and naltrexone hydrochloride) for Management of Moderate to Severe Chronic Pain
Schering-Plough Announces FDA Approval of Saphris (asenapine)
US FDA Approves Extavia (interferon beta-1b) - the First in a New Portfolio of Planned MS Therapies from Novartis to Help Patients with This Devastating Disease
Haemophilus B Conjugate Vaccine (Tetanus Toxoid Conjugate)
FDA Approves GSK's Hib Vaccine,Hiberix (Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate))
Lundbeck Inc. Announces FDA Marketing Approval for
Sabril (vigabatrin) for the Treatment of Two Difficult-to-Treat Epilepsies
FDA Approves
Xyzal (levocetirizine dihydrochloride)For Use In Children Age Six Months And Older For The Relief Of Perennial Allergic Rhinitis And Chronic Idiopathic Urticaria
Pancrelipase
Eurand Granted FDA Approval for Zenpep (pancrelipase)
FDA Approves Valcyte (valganciclovir hydrochloride) to Prevent Cytomegalovirus (CMV) Disease in Pediatric Patients Who Receive Heart or Kidney Transplants
September
Shire Announces FDA Approval of Once-Daily Intuniv (guanfacine) Extended Release Tablets for the Treatment of ADHD in Children and Adolescents Aged 6 to 17
FDA Approves Zevalin (ibritumomab tiuxetan) Expanded Label as Part of First-Line Therapy in Treatment of Follicular Non-Hodgkin's Lymphoma
Salix Receives FDA Marketing Approval for Metozolv ODT (metoclopramide) for Relief of Diabetic Gastroparesis and Symptomatic Documented GERD
Ista Pharmaceuticals' Bepreve (bepotastine) Receives FDA Approval for the Treatment of Ocular Itching Due to Allergies
Theravance and Astellas Announce FDA Approval of Vibativ (telavancin) for the Treatment of Complicated Skin and Skin Structure Infections
Sirion Therapeutics Announces FDA Approval of Zirgan (ganciclovir ophthalmic gel) 0.15% for Herpetic Keratitis
Novartis receives FDA approval for Valturna (aliskiren and valsartan), a single-pill combination of valsartan and aliskiren, to treat high blood pressure
FDA Approves Folotyn (pralatrexate) for Treatment of Peripheral T-cell Lymphoma
FDA Approves Stelara (ustekinumab) to Treat Psoriasis
Merck Receives Approval from FDA for Expanded Indications for Atypical Antipsychotic Medication Saphris (asenapine) Sublingual Tablets
October
FDA Approves Additional Use for IUD Mirena (levonorgestrel) to Treat Heavy Menstrual Bleeding in IUD Users
Welchol (colesevelam HCl) Receives FDA Approval to Lower LDL Cholesterol in Pediatric Patients with Heterozygous Familial Hypercholesterolemia
CSL Behring Announces FDA Approval of Berinert (C1 esterase inhibitor (human)), First and Only Therapy Approved for the Treatment of Acute Abdominal and Facial Attacks of Hereditary Angioedema in U.S.
U.S. Food and Drug Administration Approves Crestor (rosuvastatin calcium) for Use in Pediatric Patients With Heterozygous Familial Hypercholesterolemia
FDA Approves Elitek (rasburicase) for Management of Plasma Uric Acid Levels in Adults with Leukemia, Lymphoma, and Solid Tumors Receiving Anti-Cancer Therapy
FDA Approves Seasonal Influenza Vaccine Fluarix (influenza virus vaccine, inactivated) for Pediatric Use
FDA Approves New Use for Micardis (telmisartan) in Cardiovascular Risk Reduction
FDA Approves Twynsta (telmisartan/amlodipine) for Hypertension
FDA Approves GlaxoSmithKline’s Votrient (pazopanib) for Advanced Renal Cell Cancer
FDA Approves Colcrys (colchicine, USP) for Prevention of Gout Flares
FDA Approves Arzerra (ofatumumab) for Chronic Lymphocytic Leukemia
November
Byetta (Exenatide) approved for Expanded Use as First-Line Treatment for Type 2 Diabetes
Diclofenac Sodium
FDA Approves Pennsaid (diclofenac sodium) Topical Solution
FDA Approves Gloucester Pharmaceuticals' Istodax (romidepsin) for Patients with Cutaneous T-cell Lymphoma
FDA Approves Labeling Update for Reyataz (atazanavir sulfate) Capsules to Include 96-Week Data for Previously Untreated HIV-1 Infected Adult Patients
H1N1 Influenza Virus Vaccine
FDA Expands Approved Use of Influenza A (H1N1) Monovalent Vaccine (H1N1 influenza virus vaccine) to Include Infants and Children
Xanodyne Announces FDA Approval of Lysteda (Tranexamic Acid) for Treatment of Women with Heavy Menstrual Bleeding
NeurogesX Receives FDA Approval of Qutenza (capsaicin) 8% Patch for Treatment of Postherpetic Neuralgia (PHN)
FDA Approves Intravenous Formulation Of Pfizer's Revatio (Sildenafil) For The Treatment Of Pulmonary Arterial Hypertension
U.S. Food and Drug Administration Approves Abilify (aripiprazole) for the Treatment of Irritability Associated with Autistic Disorder in Pediatric Patients (Ages 6 to 17 Years)
FDA Approves Cymbalta (duloxetine) for Maintenance Treatment of Generalized Anxiety Disorder
FDA Grants Accelerated Approval of Istodax (romidepsin) As Treatment for Patients with Peripheral T-Cell Lymphoma Who Have Received at Least One Prior Therapy
December
FDA Approves Addition of Sustained Overall Survival Benefit to Label for Velcade (Bortezomib) for Injection for Patients with Previously Untreated Multiple Myeloma
FDA Approves OTC Version Of Heartburn Drug Zegerid (omeprazole and sodium bicarbonate)
FDA Approves 10 mcg Dose of Vagifem (estradiol) for the Treatment of Atrophic Vaginitis Due to Menopause
Dyax Announces FDA Approval of Kalbitor (ecallantide) for the Treatment of Acute Attacks of Hereditary Angioedema in Patients 16 Years of Age and Older
FDA Approves
Seroquel XR (quetiapine) For Add-On Treatment of Major Depressive Disorder
FDA Approves Lilly's Zyprexa (olanzapine) for Two Adolescent Indications
Octapharma USA Announces FDA Approval of Wilate (von Willebrand Factor/Coagulation Factor VIII Complex (Human))- the First Replacement Therapy Developed Specifically for von Willebrand Disease
FDA Approves Lilly's Zyprexa Relprevv (olanzapine) for Treatment of Schizophrenia in Adults
FDA Approves Newly Revised Prescribing Information for Azilect (rasagiline mesylate) Reducing Medication and Food Restrictions
FDA Approves
Spiriva (tiotropium bromide) HandiHaler for the Reduction of COPD Exacerbations
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