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FDA Approved Drugs in 2009
Comprehensive list of FDA approved drugs by year. Drug information includes the drug name and indication of use.
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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Triamcinolone Inhalation
Collegium Pharmaceutical Announces FDA Approval of AllerNaze (triamcinolone acetonide), a Nasal Inhaled Steroid for the Treatment of Allergic Rhinitis |
Lidocaine
Anesiva Announces FDA Approval of sNDA to Expand Zingo (lidocaine hydrochloride monohydrate) Indication to Include Adults |
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Milnacipran Hcl
Forest and Cypress Announce FDA Approval of Savella (milnacipran) for the Management of Fibromyalgia |
Fibrinogen concentrate
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 |
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Oxybutynin Hydrochloride
Watson's Gelnique (oxybutynin chloride) Gel 10% Approved by FDA for the Treatment of Overactive Bladder |
Dexlansoprazole
FDA Approves Kapidex (dexlansoprazole) for the Treatment of GERD |
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Calcitriol
Galderma Wins FDA Approval for Vectical Ointment, a Novel Topical Therapy for Mild-to-Moderate Plaque Psoriasis |
Raltegravir
HIV/AIDS Update - Traditional Approval of Isentress (raltegravir) |
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Temozolomide
United States Food and Drug Administration (FDA) Approves IV Formulation of Temodar (temozolomide) |
Antithrombin- Recombinant
ATryn (Antithrombin [Recombinant]) Approved by the FDA |
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Febuxostat
FDA Approves Uloric (febuxostat) for the Chronic Management of Hyperuricemia in Patients with Gout |
Budesonide And Formoterol
FDA Approves Symbicort (budesonide and formoterol) for Chronic Obstructive Pulmonary Disease (COPD) |
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Zolpidem
Orexo's Edluar (zolpidem) receives FDA approval for the treatment of insomnia |
Escitalopram
Forest Laboratories, Inc. Announces FDA Approval of Lexapro (escitalopram oxalate) for the Treatment of Major Depressive Disorder in Adolescents |
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Fluoxetine And Olanzapine
FDA Approves Symbyax (fluoxetine and olanzapine) as First Medication for Treatment-Resistant Depression |
Tigecycline
FDA Approves New Indication for Wyeth's Tygacil (tigecycline) for the Treatment of Adult Patients with Community-Acquired Bacterial Pneumonia |
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Everolimus
Afinitor (everolimus) approved in US as first treatment for patients with advanced kidney cancer after failure of either sunitinib or sorafenib |
Japanese Encephalitis Virus Vaccine
Intercell Announces FDA Approval of Ixiaro (Japanese Encephalitis Virus Vaccine, Inactivated, Adsorbed) , a Novel Vaccine to Prevent Japanese Encephalitis |
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Artemether And Lumefantrine
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 |
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Golimumab
Simponi (golimumab) Receives FDA Approval as First Once-Monthly Anti-TNF for Treatment of Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis |
Abobotulinumtoxin A Injection
FDA Approves Dysport (abobotulinumtoxinA) for Therapeutic and Aesthetic Uses |
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Amlodipine, Valsartan And Hydrochlorothiazide
FDA approves Exforge HCT (amlodipine, valsartan and hydrochlorothiazide) - the only high blood pressure treatment to combine three medications in a single pill |
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Ciprofloxacin
FDA Approves Cetraxal (ciprofloxacin otic) Otic Solution |
Bevacizumab
FDA Grants Accelerated Approval of Avastin (bevacizumab) for Brain Cancer (Glioblastoma) That Has Progressed Following Prior Therapy |
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Bromocriptine Mesylate
VeroScience Announces FDA Approval of Cycloset (bromocriptine mesylate) for Treatment of Type 2 Diabetes |
Iloperidone
FDA Approves Fanapt (iloperidone) to Treat Schizophrenia |
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Lamotrigine
FDA Approves Lamictal (lamotrigine) ODT Orally Disintegrating Tablets |
Amlodipine And Olmesartan
Azor (amlodipine and olmesartan) Receives FDA Approval as First-Line Treatment for High Blood Pressure |
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Pioglitazone And Metformin
FDA Approves ACTOplus met XR (pioglitazone HCl and metformin HCl extended-release) Tablets for the Treatment of Type 2 Diabetes |
Certolizumab
UCB's Cimzia (certolizumab pegol) Approved by the U.S. FDA for Adult Patients Suffering From Moderate to Severe Rheumatoid Arthritis |
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Lansoprazole
Novartis Receives Approval From FDA To Market Prevacid (lansoprazole) 24HR As First And Only OTC Proton Pump Inhibitor In Original Prescription Formulation |
Risperidone
FDA Grants Approval for Use of Risperdal (risperidone) Consta as Both a Monotherapy and Adjunctive Therapy in the Maintenance Treatment of Bipolar I Disorder |
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Tolvaptan
FDA Approves Samsca (tolvaptan), the First and Only Oral Vasopressin Antagonist to Treat Patients With Clinically Significant Hypervolemic and Euvolemic Hyponatremia |
Tadalafil
FDA Approves Adcirca (tadalafil) Tablets for the Treatment of Pulmonary Arterial Hypertension |
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Dasatinib
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 |
Tacrolimus
Astellas Receives FDA Approval for Use of Prograf (Tacrolimus) in Conjunction With Mycophenolate Mofetil (MMF) in Kidney Transplant Recipients |
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Besifloxacin Ophthalmic Suspension
Bausch & Lomb Receives FDA Approval of Besivance (besifloxacin), New Topical Ophthalmic Antibacterial for the Treatment of Bacterial Conjunctivitis ('Pink Eye') |
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Zoledronic Acid
FDA Approves Reclast (zoledronic acid) to Prevent Osteoporosis in Postmenopausal Women With Convenient Less Frequent Dosing |
Ibuprofen
Cumberland Pharmaceuticals Announces FDA Approval of Caldolor (ibuprofen) |
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Canakinumab
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 |
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Diclofenac
FDA Approves Cambia (diclofenac potassium)for Migraine |
Ferumoxytol
FDA Approves Feraheme (ferumoxytol) to Treat Iron Deficiency Anemia in Adult Chronic Kidney Disease Patients |
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Dronedarone
FDA Approves Multaq (dronedarone) for Patients with Atrial Fibrillation or Atrial Flutter |
Pemetrexed
Lilly Receives Fourth FDA Approval for Alimta (pemetrexed for injection) as Maintenance Therapy For Nonsquamous Non-Small Cell Lung Cancer |
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Prasugrel
Daiichi Sankyo and Lilly Receive U.S. FDA Approval for Effient (prasugrel) |
Levonorgestrel
FDA Approves Plan B One-Step (levonorgestrel) , a New One-Pill Emergency Contraceptive |
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Sumatriptan
Sumavel DosePro (sumatriptan injection) Approved by FDA for Acute Migraine and Cluster Headache: First Product Featuring Novel DosePro Needle-Free Delivery System |
Fentanyl Buccal Soluble Film
BioDelivery Sciences and Meda Announce FDA Approval of Onsolis (fentanyl) |
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Insulin Aspart
FDA Approves NovoLog (insulin aspart) Labeling Update |
Aliskiren And Hydrochlorothiazide
FDA Approves Tekturna HCT (aliskiren and hydrochlorothiazide) as Initial Treatment in Patients Unlikely to Achieve Their Blood Pressure Goals With a Single Agent |
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Ketorolac Trometamol Ophthalmic
Allergan Receives FDA Approval for Acuvail (ketorolac tromethamine) Ophthalmic Solution for the Treatment of Pain and Inflammation Following Cataract Surgery |
Teriparatide
FDA Approves Expanded Use of Lilly's Forteo [teriparatide (rDNA origin) injection] to Treat Glucocorticoid-Induced Osteoporosis |
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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 |
Treprostinil
FDA Approves Tyvaso (treprostinil) Inhalation Solution for the Treatment of Pulmonary Arterial Hypertension |
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Colchicine
FDA Approves Colcrys (colchicine) for Acute Gout, Mediterranean Fever |
Saxagliptin
FDA Approves Onglyza (saxagliptin) for Type 2 Diabetes |
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Acyclovir And Hydrocortisone
The US FDA approves Lipsovir (acyclovir and hydrocortisone) for marketing and sales in US |
Bevacizumab
FDA Approves Avastin for the Most Common Type of Kidney Cancer |
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Paliperidone
Invega Approved as the First and Only Treatment for Schizoaffective Disorder |
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Pitavastatin
FDA Approves Livalo (pitavastatin) for Primary Hypercholesterolemia and Combined Dyslipidemia |
Morphine Sulfate And Naltrexone Hydrochloride
FDA Approves Embeda (morphine sulfate and naltrexone hydrochloride) for Management of Moderate to Severe Chronic Pain |
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Asenapine
Schering-Plough Announces FDA Approval of Saphris (asenapine) |
Interferon Beta-1B
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 |
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Haemophilus B Conjugate Vaccine (Tetanus Toxoid Conjugate)
FDA Approves GSK's Hib Vaccine,Hiberix (Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)) |
Vigabatrin
Lundbeck Inc. Announces FDA Marketing Approval for Sabril (vigabatrin) for the Treatment of Two Difficult-to-Treat Epilepsies |
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Levocetirizine
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) |
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Valganciclovir
FDA Approves Valcyte (valganciclovir hydrochloride) to Prevent Cytomegalovirus (CMV) Disease in Pediatric Patients Who Receive Heart or Kidney Transplants |
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Guanfacine
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 |
Ibritumomab Tiuxetan
FDA Approves Zevalin (ibritumomab tiuxetan) Expanded Label as Part of First-Line Therapy in Treatment of Follicular Non-Hodgkin's Lymphoma |
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Metoclopramide
Salix Receives FDA Marketing Approval for Metozolv ODT (metoclopramide) for Relief of Diabetic Gastroparesis and Symptomatic Documented GERD |
Bepotastine
Ista Pharmaceuticals' Bepreve (bepotastine) Receives FDA Approval for the Treatment of Ocular Itching Due to Allergies |
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Telavancin
Theravance and Astellas Announce FDA Approval of Vibativ (telavancin) for the Treatment of Complicated Skin and Skin Structure Infections |
Ganciclovir
Sirion Therapeutics Announces FDA Approval of Zirgan (ganciclovir ophthalmic gel) 0.15% for Herpetic Keratitis |
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Aliskiren And Valsartan
Novartis receives FDA approval for Valturna (aliskiren and valsartan), a single-pill combination of valsartan and aliskiren, to treat high blood pressure |
Pralatrexate Solution
FDA Approves Folotyn (pralatrexate) for Treatment of Peripheral T-cell Lymphoma |
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Ustekinumab
FDA Approves Stelara (ustekinumab) to Treat Psoriasis |
Asenapine
Merck Receives Approval from FDA for Expanded Indications for Atypical Antipsychotic Medication Saphris (asenapine) Sublingual Tablets |
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Levonorgestrel
FDA Approves Additional Use for IUD Mirena (levonorgestrel) to Treat Heavy Menstrual Bleeding in IUD Users |
Colesevelam Hcl
Welchol (colesevelam HCl) Receives FDA Approval to Lower LDL Cholesterol in Pediatric Patients with Heterozygous Familial Hypercholesterolemia |
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C- 1 esterase inhibitor
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. |
Rosuvastatin
U.S. Food and Drug Administration Approves Crestor (rosuvastatin calcium) for Use in Pediatric Patients With Heterozygous Familial Hypercholesterolemia |
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Rasburicase
FDA Approves Elitek (rasburicase) for Management of Plasma Uric Acid Levels in Adults with Leukemia, Lymphoma, and Solid Tumors Receiving Anti-Cancer Therapy |
Influenza Virus Vaccine
FDA Approves Seasonal Influenza Vaccine Fluarix (influenza virus vaccine, inactivated) for Pediatric Use |
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Telmisartan
FDA Approves New Use for Micardis (telmisartan) in Cardiovascular Risk Reduction |
Telmisartan And Amlodipine
FDA Approves Twynsta (telmisartan/amlodipine) for Hypertension |
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Pazopanib
FDA Approves GlaxoSmithKline’s Votrient (pazopanib) for Advanced Renal Cell Cancer |
Colchicine
FDA Approves Colcrys (colchicine, USP) for Prevention of Gout Flares |
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Ofatumumab
FDA Approves Arzerra (ofatumumab) for Chronic Lymphocytic Leukemia |
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Exenatide
Byetta (Exenatide) approved for Expanded Use as First-Line Treatment for Type 2 Diabetes |
Diclofenac Sodium
FDA Approves Pennsaid (diclofenac sodium) Topical Solution |
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Romidepsin
FDA Approves Gloucester Pharmaceuticals' Istodax (romidepsin) for Patients with Cutaneous T-cell Lymphoma |
Atazanavir
FDA Approves Labeling Update for Reyataz (atazanavir sulfate) Capsules to Include 96-Week Data for Previously Untreated HIV-1 Infected Adult Patients |
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H1N1 Influenza Virus Vaccine
FDA Expands Approved Use of Influenza A (H1N1) Monovalent Vaccine (H1N1 influenza virus vaccine) to Include Infants and Children |
Tranexamic Acid
Xanodyne Announces FDA Approval of Lysteda (Tranexamic Acid) for Treatment of Women with Heavy Menstrual Bleeding |
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Capsaicin
NeurogesX Receives FDA Approval of Qutenza (capsaicin) 8% Patch for Treatment of Postherpetic Neuralgia (PHN) |
Sildenafil
FDA Approves Intravenous Formulation Of Pfizer's Revatio (Sildenafil) For The Treatment Of Pulmonary Arterial Hypertension |
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Aripiprazole
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) |
Duloxetine
FDA Approves Cymbalta (duloxetine) for Maintenance Treatment of Generalized Anxiety Disorder |
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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 |
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Bortezomib
FDA Approves Addition of Sustained Overall Survival Benefit to Label for Velcade (Bortezomib) for Injection for Patients with Previously Untreated Multiple Myeloma |
Omeprazole And Sodium Bicarbonate
FDA Approves OTC Version Of Heartburn Drug Zegerid (omeprazole and sodium bicarbonate) |
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Estradiol
FDA Approves 10 mcg Dose of Vagifem (estradiol) for the Treatment of Atrophic Vaginitis Due to Menopause |
Ecallantide
Dyax Announces FDA Approval of Kalbitor (ecallantide) for the Treatment of Acute Attacks of Hereditary Angioedema in Patients 16 Years of Age and Older |
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Quetiapine
FDA Approves Seroquel XR (quetiapine) For Add-On Treatment of Major Depressive Disorder |
Olanzapine
FDA Approves Lilly's Zyprexa (olanzapine) for Two Adolescent Indications |
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Antihemophiliac factor
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 |
Olanzapine
FDA Approves Lilly's Zyprexa Relprevv (olanzapine) for Treatment of Schizophrenia in Adults |
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Rasagiline
FDA Approves Newly Revised Prescribing Information for Azilect (rasagiline mesylate) Reducing Medication and Food Restrictions |
Tiotropium
FDA Approves Spiriva (tiotropium bromide) HandiHaler for the Reduction of COPD Exacerbations |
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