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FDA Approved Drugs in 2009


Comprehensive list of FDA approved drugs in the year 2009. Drug information includes the drug name and indication of use.

January

Calcitriol


Galderma Wins FDA Approval for Vectical Ointment, a Novel Topical Therapy for Mild-to-Moderate Plaque Psoriasis

Dexlansoprazole


FDA Approves Kapidex (dexlansoprazole) for the Treatment of GERD

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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Lidocaine


Anesiva Announces FDA Approval of sNDA to Expand Zingo (lidocaine hydrochloride monohydrate) Indication to Include Adults

Milnacipran Hcl


Forest and Cypress Announce FDA Approval of Savella (milnacipran) for the Management of Fibromyalgia

Oxybutynin Hydrochloride


Watson's Gelnique (oxybutynin chloride) Gel 10% Approved by FDA for the Treatment of Overactive Bladder

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Raltegravir


HIV/AIDS Update - Traditional Approval of Isentress (raltegravir)

Triamcinolone Inhalation


Collegium Pharmaceutical Announces FDA Approval of AllerNaze (triamcinolone acetonide), a Nasal Inhaled Steroid for the Treatment of Allergic Rhinitis

February

Antithrombin- Recombinant


ATryn (Antithrombin [Recombinant]) Approved by the FDA

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Budesonide And Formoterol


FDA Approves Symbicort (budesonide and formoterol) for Chronic Obstructive Pulmonary Disease (COPD)

Febuxostat


FDA Approves Uloric (febuxostat) for the Chronic Management of Hyperuricemia in Patients with Gout

Temozolomide


United States Food and Drug Administration (FDA) Approves IV Formulation of Temodar (temozolomide)

March

Escitalopram


Forest Laboratories, Inc. Announces FDA Approval of Lexapro (escitalopram oxalate) for the Treatment of Major Depressive Disorder in Adolescents

Everolimus


Afinitor (everolimus) approved in US as first treatment for patients with advanced kidney cancer after failure of either sunitinib or sorafenib

Fluoxetine And Olanzapine


FDA Approves Symbyax (fluoxetine and olanzapine) as First Medication for Treatment-Resistant Depression

Japanese Encephalitis Virus Vaccine


Intercell Announces FDA Approval of Ixiaro (Japanese Encephalitis Virus Vaccine, Inactivated, Adsorbed) , a Novel Vaccine to Prevent Japanese Encephalitis

Tigecycline


FDA Approves New Indication for Wyeth's Tygacil (tigecycline) for the Treatment of Adult Patients with Community-Acquired Bacterial Pneumonia

Zolpidem


Orexo's Edluar (zolpidem) receives FDA approval for the treatment of insomnia

April

Abobotulinumtoxin A Injection


FDA Approves Dysport (abobotulinumtoxinA) for Therapeutic and Aesthetic Uses

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

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

Golimumab


Simponi (golimumab) Receives FDA Approval as First Once-Monthly Anti-TNF for Treatment of Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis

May

Amlodipine And Olmesartan


Azor (amlodipine and olmesartan) Receives FDA Approval as First-Line Treatment for High Blood Pressure

Besifloxacin Ophthalmic Suspension


Bausch & Lomb Receives FDA Approval of Besivance (besifloxacin), New Topical Ophthalmic Antibacterial for the Treatment of Bacterial Conjunctivitis ('Pink Eye')

Bevacizumab


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

Certolizumab


UCB's Cimzia (certolizumab pegol) Approved by the U.S. FDA for Adult Patients Suffering From Moderate to Severe Rheumatoid Arthritis

Ciprofloxacin


FDA Approves Cetraxal (ciprofloxacin otic) Otic Solution

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

Iloperidone


FDA Approves Fanapt (iloperidone) to Treat Schizophrenia

Lamotrigine


FDA Approves Lamictal (lamotrigine) ODT Orally Disintegrating Tablets

Lansoprazole


Novartis Receives Approval From FDA To Market Prevacid (lansoprazole) 24HR As First And Only OTC Proton Pump Inhibitor In Original Prescription Formulation

Pioglitazone And Metformin


FDA Approves ACTOplus met XR (pioglitazone HCl and metformin HCl extended-release) Tablets for the Treatment of Type 2 Diabetes

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

Tacrolimus


Astellas Receives FDA Approval for Use of Prograf (Tacrolimus) in Conjunction With Mycophenolate Mofetil (MMF) in Kidney Transplant Recipients

Tadalafil


FDA Approves Adcirca (tadalafil) Tablets for the Treatment of Pulmonary Arterial Hypertension

Tolvaptan


FDA Approves Samsca (tolvaptan), the First and Only Oral Vasopressin Antagonist to Treat Patients With Clinically Significant Hypervolemic and Euvolemic Hyponatremia

June

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

Diclofenac


FDA Approves Cambia (diclofenac potassium)for Migraine

Ferumoxytol


FDA Approves Feraheme (ferumoxytol) to Treat Iron Deficiency Anemia in Adult Chronic Kidney Disease Patients

Ibuprofen


Cumberland Pharmaceuticals Announces FDA Approval of Caldolor (ibuprofen)

Zoledronic Acid


FDA Approves Reclast (zoledronic acid) to Prevent Osteoporosis in Postmenopausal Women With Convenient Less Frequent Dosing

July

Acyclovir And Hydrocortisone


The US FDA approves Lipsovir (acyclovir and hydrocortisone) for marketing and sales in US

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

Bevacizumab


FDA Approves Avastin for the Most Common Type of Kidney Cancer

Colchicine


FDA Approves Colcrys (colchicine) for Acute Gout, Mediterranean Fever

Dronedarone


FDA Approves Multaq (dronedarone) for Patients with Atrial Fibrillation or Atrial Flutter

Fentanyl Buccal Soluble Film


BioDelivery Sciences and Meda Announce FDA Approval of Onsolis (fentanyl)

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

Insulin Aspart


FDA Approves NovoLog (insulin aspart) Labeling Update

Ketorolac Trometamol Ophthalmic


Allergan Receives FDA Approval for Acuvail (ketorolac tromethamine) Ophthalmic Solution for the Treatment of Pain and Inflammation Following Cataract Surgery

Levonorgestrel


FDA Approves Plan B One-Step (levonorgestrel) , a New One-Pill Emergency Contraceptive

Paliperidone


Invega Approved as the First and Only Treatment for Schizoaffective Disorder

Pemetrexed


Lilly Receives Fourth FDA Approval for Alimta (pemetrexed for injection) as Maintenance Therapy For Nonsquamous Non-Small Cell Lung Cancer

Prasugrel


Daiichi Sankyo and Lilly Receive U.S. FDA Approval for Effient (prasugrel)

Saxagliptin


FDA Approves Onglyza (saxagliptin) for Type 2 Diabetes

Teriparatide


FDA Approves Expanded Use of Lilly's Forteo [teriparatide (rDNA origin) injection] to Treat Glucocorticoid-Induced Osteoporosis

Treprostinil


FDA Approves Tyvaso (treprostinil) Inhalation Solution for the Treatment of Pulmonary Arterial Hypertension

August

Asenapine


Schering-Plough Announces FDA Approval of Saphris (asenapine)

Haemophilus B Conjugate Vaccine (Tetanus Toxoid Conjugate)


FDA Approves GSK's Hib Vaccine,Hiberix (Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate))

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

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

Morphine Sulfate And Naltrexone Hydrochloride


FDA Approves Embeda (morphine sulfate and naltrexone hydrochloride) for Management of Moderate to Severe Chronic Pain

Pancrelipase


Eurand Granted FDA Approval for Zenpep (pancrelipase)

Pitavastatin


FDA Approves Livalo (pitavastatin) for Primary Hypercholesterolemia and Combined Dyslipidemia

Valganciclovir


FDA Approves Valcyte (valganciclovir hydrochloride) to Prevent Cytomegalovirus (CMV) Disease in Pediatric Patients Who Receive Heart or Kidney Transplants

Vigabatrin


Lundbeck Inc. Announces FDA Marketing Approval for Sabril (vigabatrin) for the Treatment of Two Difficult-to-Treat Epilepsies

September

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

Asenapine


Merck Receives Approval from FDA for Expanded Indications for Atypical Antipsychotic Medication Saphris (asenapine) Sublingual Tablets

Bepotastine


Ista Pharmaceuticals' Bepreve (bepotastine) Receives FDA Approval for the Treatment of Ocular Itching Due to Allergies

Ganciclovir


Sirion Therapeutics Announces FDA Approval of Zirgan (ganciclovir ophthalmic gel) 0.15% for Herpetic Keratitis

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

Metoclopramide


Salix Receives FDA Marketing Approval for Metozolv ODT (metoclopramide) for Relief of Diabetic Gastroparesis and Symptomatic Documented GERD

Pralatrexate Solution


FDA Approves Folotyn (pralatrexate) for Treatment of Peripheral T-cell Lymphoma

Telavancin


Theravance and Astellas Announce FDA Approval of Vibativ (telavancin) for the Treatment of Complicated Skin and Skin Structure Infections

Ustekinumab


FDA Approves Stelara (ustekinumab) to Treat Psoriasis

October

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.

Colchicine


FDA Approves Colcrys (colchicine, USP) for Prevention of Gout Flares

Colesevelam Hcl


Welchol (colesevelam HCl) Receives FDA Approval to Lower LDL Cholesterol in Pediatric Patients with Heterozygous Familial Hypercholesterolemia

Influenza Virus Vaccine


FDA Approves Seasonal Influenza Vaccine Fluarix (influenza virus vaccine, inactivated) for Pediatric Use

Levonorgestrel


FDA Approves Additional Use for IUD Mirena (levonorgestrel) to Treat Heavy Menstrual Bleeding in IUD Users

Ofatumumab


FDA Approves Arzerra (ofatumumab) for Chronic Lymphocytic Leukemia

Pazopanib


FDA Approves GlaxoSmithKline’s Votrient (pazopanib) for Advanced Renal Cell Cancer

Rasburicase


FDA Approves Elitek (rasburicase) for Management of Plasma Uric Acid Levels in Adults with Leukemia, Lymphoma, and Solid Tumors Receiving Anti-Cancer Therapy

Rosuvastatin


U.S. Food and Drug Administration Approves Crestor (rosuvastatin calcium) for Use in Pediatric Patients With Heterozygous Familial Hypercholesterolemia

Telmisartan


FDA Approves New Use for Micardis (telmisartan) in Cardiovascular Risk Reduction

Telmisartan And Amlodipine


FDA Approves Twynsta (telmisartan/amlodipine) for Hypertension

November

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)

Atazanavir


FDA Approves Labeling Update for Reyataz (atazanavir sulfate) Capsules to Include 96-Week Data for Previously Untreated HIV-1 Infected Adult Patients

Capsaicin


NeurogesX Receives FDA Approval of Qutenza (capsaicin) 8% Patch for Treatment of Postherpetic Neuralgia (PHN)

Diclofenac Sodium


FDA Approves Pennsaid (diclofenac sodium) Topical Solution

Duloxetine


FDA Approves Cymbalta (duloxetine) for Maintenance Treatment of Generalized Anxiety Disorder

Exenatide


Byetta (Exenatide) approved for Expanded Use as First-Line Treatment for Type 2 Diabetes

H1N1 Influenza Virus Vaccine


FDA Expands Approved Use of Influenza A (H1N1) Monovalent Vaccine (H1N1 influenza virus vaccine) to Include Infants and Children

Romidepsin


FDA Approves Gloucester Pharmaceuticals' Istodax (romidepsin) for Patients with Cutaneous T-cell Lymphoma

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

Sildenafil


FDA Approves Intravenous Formulation Of Pfizer's Revatio (Sildenafil) For The Treatment Of Pulmonary Arterial Hypertension

Tranexamic Acid


Xanodyne Announces FDA Approval of Lysteda (Tranexamic Acid) for Treatment of Women with Heavy Menstrual Bleeding

December

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

Bortezomib


FDA Approves Addition of Sustained Overall Survival Benefit to Label for Velcade (Bortezomib) for Injection for Patients with Previously Untreated Multiple Myeloma

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

Estradiol


FDA Approves 10 mcg Dose of Vagifem (estradiol) for the Treatment of Atrophic Vaginitis Due to Menopause

Olanzapine


FDA Approves Lilly's Zyprexa (olanzapine) for Two Adolescent Indications

Olanzapine


FDA Approves Lilly's Zyprexa Relprevv (olanzapine) for Treatment of Schizophrenia in Adults

Omeprazole And Sodium Bicarbonate


FDA Approves OTC Version Of Heartburn Drug Zegerid (omeprazole and sodium bicarbonate)

Quetiapine


FDA Approves Seroquel XR (quetiapine) For Add-On Treatment of Major Depressive Disorder

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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