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FDA Approved Drugs in 2010

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

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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

January
Tocilizumab Injection
FDA Approves Actemra (tocilizumab) for the Treatment of Moderately to Severely Active Rheumatoid Arthritis
Emtricitabine- Rilpivirine- Tenofovir
HIV/AIDS Update - Atripla (efavirenz, emtricitabine and tenofovir disoproxil fumarate) label update reflects new efficacy, safety and resistance data in treatment experienced patients
Dalfampridine
FDA Approves Ampyra (dalfampridine)to Improve Walking in Adults with Multiple Sclerosis
Liraglutide [rDNA] Injection
FDA Approves Novo-Nordisk's Diabetes Drug Victoza (liraglutide)
Darunavir
U.S. Food and Drug Administration Approves Labeling Update for Prezista (darunavir) To Include 96-Week Data in HIV-1 Infected Adult Patients
Lapatinib
GSK's Tykerb (lapatinib ditosylate) Receives Accelerated Approval for First-Line Combination Treatment of Metastatic Breast Cancer

February
Trazodone
Labopharm Receives FDA Approval for Oleptro (trazodone)
Collagenase Clostridium Histolyticum
Auxilium Announces U.S. Food and Drug Administration Approval for Xiaflex (collagenase clostridium histolyticum) for the Treatment of Dupuytren's Contracture
Lamotrigine
FDA Approves Once-A-Day Lamictal XR (lamotrigine) as Add-On Epilepsy Therapy for Primary Generalized Tonic-Clonic Seizures
Rosuvastatin
FDA Approves Crestor (rosuvastatin calcium) to Reduce Stroke, Heart Attack Risk
Olmesartan
FDA Approves Benicar (olmesartan medoxomil) for the Treatment of High Blood Pressure in Children and Adolescents aged 6-16
Ritonavir
Abbott Receives U.S. FDA Approval for Heat-Stable Norvir (ritonavir) Tablets
Rituximab
FDA Approves Rituxan (rituximab) to Treat Chronic Lymphocytic Leukemia
Meningococcal Conjugate Vaccine
Novartis Gets US Approval for Menveo (meningococcal conjugate vaccine) Meningitis Vaccine
Aztreonam
U.S. Food and Drug Administration Approves Cayston (Aztreonam for Inhalation Solution) for the Improvement of Respiratory Symptoms in Cystic Fibrosis Patients with Pseudomonas Aeruginosa
Pneumococcal Vaccine Polyvalent
FDA Approves Prevnar 13 (pneumococcal 13-valent conjugate vaccine) Pneumococcal Disease Vaccine
Velaglucerase Alfa for Injection
FDA Approves VPRIV (velaglucerase alfa) to Treat Gaucher Disease
Pneumococcal Vaccine Polyvalent
FDA Expands Use of Prevnar 13 (pneumococcal 13-valent conjugate vaccine)Vaccine for People Ages 50 and Older

March
Hydromorphone
FDA Approves Exaglo (hydromorphone HCl) Extended-Release Tablets
Somatropin
Novo Nordisk Receives FDA Approval for Norditropin FlexPro for Growth Hormone Treatment
Immune Globulin Subcutaneous
CSL Behring Receives FDA Approval of Hizentra, First 20 Percent Subcutaneous Immunoglobulin Therapy
Onabotulinumtoxina
Botox (onabotulinumtoxinA) Receives FDA Approval for Treatment of Upper Limb Spasticity in Adults
Decitabine
FDA Approves Five-Day Dosing Regimen for Dacogen (decitabine) for Injection, Offering a New Outpatient Dosing Option for Myelodysplastic Syndromes (MDS)
Triptorelin Pamoate for Injectable Suspension
FDA Approves Watson's Trelstar 22.5 mg, the First and Only 6-Month Intramuscular GnRH Agonist for the Palliative Treatment of Advanced Prostate Cancer
Doxepin
Somaxon Announces FDA Approval of Silenor (doxepin) for the Treatment of Insomnia
Carglumic Acid
FDA Approves Carbaglu to Treat Condition That Causes Elevated Ammonia Levels
Adapalene
Galderma Received FDA Approval of Differin (adapalene) Lotion, 0.1%, the First Retinoid Available in Lotion Formulation
Pramipexole
Once-Daily Mirapex ER Now Approved by FDA for Both Early and Advanced Parkinson's Disease
Rifaximin
FDA Approves New Use of Xifaxan for Patients with Liver Disease
Imiquimod
FDA Approves Zyclara (imiquimod) Cream, 3.75% for the Treatment of Actinic Keratoses
Polidocanol Injection
FDA Approves Asclera to Treat Small Varicose Veins
Imiquimod
FDA Approves Zyclara (imiquimod) Cream, 3.75% for the Treatment of External Genital Warts
Imiquimod
FDA Approves Zyclara (imiquimod) Cream, 2.5% for the Treatment of Actinic Keratoses

April
Oxycodone Hydrochloride
FDA Approves New Formulation for OxyContin (oxycodone)
Pancrelipase
FDA Approves Pancreatic Enzyme Product, Pancreaze (pancrelipase)
Miconazole
FDA Approves Oravig (miconazole) Buccal Tablets for Treatment of Oropharyngeal Candidiasis
Erlotinib
FDA Approves Tarceva (erlotinib) as a Maintenance Therapy for Advanced Non-Small Cell Lung Cancer
Immune globulin intravenous
CSL Behring Receives FDA Approval to Extend Shelf Life for Privigen (immune globulin intravenous (human)) from 24 to 36 Months
Everolimus
Novartis Receives US FDA Approval for Zortress (everolimus) to Prevent Organ Rejection in Adult Kidney Transplant Recipients
Lopinavir And Ritonavir
Abbott Receives FDA Approval for Once-Daily Dosing of Kaletra (lopinavir / ritonavir) for Treatment-Experienced Patients
Sipuleucel-T Suspension
FDA Approves Provenge (sipuleucel-T) - a Cellular Immunotherapy for Men With Advanced Prostate Cancer
Naproxen And Esomeprazole Magnesium
FDA Approved Vimovo for Arthritis Patients At Risk of Developing NSAID-Associated Gastric Ulcers

May
Pancrelipase
Abbott Receives FDA Approval for Creon (pancrelipase) to Include Dosing Information for Patients With Chronic Pancreatitis and Pancreatectomy
Dienogest And Estradiol Valerate
FDA Approves Natazia (dienogest and estradiol valerate) - New Combination Product Oral Contraceptive
Gatifloxacin
Allergan Receives FDA Approval for Zymaxid (gatifloxacin) Ophthalmic Solution
Alglucosidase
FDA Approves Lumizyme (alglucosidase alfa) for Late-Onset Pompe Disease
Hexaminolevulinate Hydrochloride
Cysview (Hexaminolevulinate HCl) Approved by the FDA for Cystoscopic Detection of Papillary Bladder Cancer

June
Dutasteride And Tamsulosin
FDA approves Jalyn (dutasteride and tamsulosin) , a fixed-dose combination of dutasteride and tamsulosin, for symptomatic BPH in men with an enlarged prostate
Cabazitaxel
Jevtana (cabazitaxel) Injection Approved by U.S. FDA After Priority Review
Nilotinib
Novartis International AG (CH) - FDA approves Tasigna (nilotinib) for newly diagnosed chronic myeloid leukemia patients, data demonstrate major advance over Glivec
Vardenafil
FDA approves Staxyn (vardenafil HCl) orally disintegrating tablets for erectile dysfunction (ED)
Memantine
Forest and Merz Announce FDA Approval of Namenda (memantine hydrochloride) XR for the Treatment of Moderate to Severe Dementia of the Alzheimer's Type
Ranibizumab
FDA Approves Lucentis (Ranibizumab Injection) for the Treatment of Macular Edema Following Retinal Vein Occlusion
Mometasone Furoate And Formoterol Fumarate
FDA Approves Merck's Dulera (mometasone furoate and formoterol fumarate dihydrate) Inhalation Aerosol for the Treatment of Asthma in Patients 12 Years of Age and Older
Buprenorphine
Purdue Pharma L.P. Receives FDA Approval for Butrans (buprenorphine) Transdermal System CIII
Sumatriptan
FDA Approves Alsuma (sumatriptan) Auto-Injector
Denosumab
FDA Approves New Indications for Prolia (denosumab) for the Treatment of Bone Loss in Patients With Prostate or Breast Cancer Undergoing Hormone Ablation Therapy
Denosumab
FDA Approves Amgen's Prolia (Denosumab) for Treatment of Postmenopausal Women With Osteoporosis at High Risk for Fracture

July
Ondansetron
FDA Approves Strativa Pharmaceuticals' Zuplenz (ondansetron) Oral Soluble Film
Interferon Alfacon-1
Three Rivers Pharmaceuticals Announces FDA Approval Of Expanded Labeling of Infergen (interferon alfacon-1)
Alpha One-proteinase inhibitor
Kamada Wins FDA Approval for Glassia (alpha1-proteinase inhibitor (human)) - a New Liquid, Ready-to-Use Treatment for Alpha-1 Antitrypsin Deficiency
Methylphenidate
FDA Approves Daytrana (methylphenidate transdermal system) CII for the Treatment of ADHD in Adolescents
Clindamycin And Tretinoin
Stiefel, a GSK company, Receives FDA Approval of Veltin (clindamycin phosphate and tretinoin) Gel 1.2%/0.025%
Donepezil
Eisai Inc. and Pfizer Inc Announce U.S. FDA Approval for New Higher-Dose Aricept (donepezil HCl) 23 mg Tablet for the Treatment of Moderate-to-Severe Alzheimer's Disease
Amlodipine , Hydrochlorothiazide and Olmesartan
FDA Approves Tribenzor (amlodipine, hydrochlorothiazide and olmesartan) , A New Three-In-One Combination Product for the Treatment of High Blood Pressure
Alcaftadine Ophthalmic Solution
FDA Approves Lastacaft (alcaftadine ophthalmic solution) for Prevention of Itching Associated with Allergic Conjunctivitis
Glycopyrolate
FDA Approves Cuvposa (glycopyrrolate) for Chronic Drooling in Children
Niacin Er And Simvastatin
Abbott's Simcor (niacin extended-release/simvastatin) Receives FDA Approval for New Dosage Strengths

August
Valganciclovir
FDA Approves Longer Use of Valcyte (valganciclovir) for Adult Kidney Transplant Patients at High Risk of Developing Cytomegalovirus (CMV) Disease
Ulipristal Acetate
FDA Approves ella (ulipristal acetate) Tablets for Prescription Emergency Contraception
Aliskiren And Amlodipine
Novartis receives FDA approval of Tekamlo (aliskiren and amlodipine), a single-pill combination of aliskiren and amlodipine to treat high blood pressure
Buprenorphine And Naloxone
Reckitt Benckiser Pharmaceuticals Inc. Receives FDA Approval for Suboxone (buprenorphine and naloxone) Sublingual Film C-III
Docetaxel
FDA Approves New Taxotere (docetaxel) Injection Concentrate Formulation
Sodium- Potassium- Magnesium Sulfate
FDA Approves Suprep (sodium sulfate, potassium sulfate, magnesium sulfate) Bowel Prep Kit

September
Fulvestrant
FDA Approves New Dosing for Faslodex (fulvestrant) Injection in Treatment of Metastatic Breast Cancer in HR+ Postmenopausal Women
Pralidoxime
FDA Approves Pediatric Use of Protopam Chloride (pralidoxime chloride) Chemical Poisoning Treatment
Pegloticase
FDA Approves Krystexxa (pegloticase) for Gout
Asenapine
Merck Receives Approval from FDA for Expanded Indications for Atypical Antipsychotic Medication Saphris (asenapine) Sublingual Tablets
Fingolimod
Novartis Gains FDA Approval For Gilenya (fingolimod), A Novel First-Line Multiple Sclerosis Treatment Shown To Significantly Reduce Relapses And Delay Disability Progression
Dexamethasone Ophthalmic
Allergan Receives FDA Approval for Ozurdex (dexamethasone) as Treatment Option for Non-Infectious Uveitis Affecting the Posterior Segment of the Eye
Clonidine
Shionogi Announces FDA Approval of Kapvay (clonidine hydrochloride) - The First and Only Therapy Approved for Use with Stimulant Medication for the Treatment of ADHD
Bimatoprost
Allergan, Inc. Receives FDA Approval for Lumigan 0.01% as First-Line Therapy Indicated for the Reduction of Elevated Intraocular Pressure in Glaucoma Patients

October
Mannitol
United States Food and Drug Administration Approves Aridol (mannitol)
Risedronate
Warner Chilcott Announces FDA Approval of Atelvia (risedronate sodium) Next Generation Actonel
Calcipotriene
Stiefel, a GSK company, Receives FDA Approval of Sorilux (calcipotriene) Foam, 0.005%
Naltrexone
FDA Approves Vivitrol (naltrexone) to Treat Opioid-dependent Patients
Immune Globulin Intravenous And Subcutaneous
Talecris Biotherapeutics Receives FDA Approval for Gamunex-C (immune globulin intravenous and subcutaneous)
Corticotropin
FDA Approves H.P. Acthar Gel (corticotropin) for the Treatment of Infantile Spasms
Entecavir
U.S. Food and Drug Administration Approves Baraclude (entecavir) as a Treatment for Chronic Hepatitis B Patients with Evidence of Decompensated Liver Disease
Dabigatran
FDA Approves Pradaxa (dabigatran etexilate) to Prevent Stroke in People With Atrial Fibrillation
Bromfenac Ophthalmic Solution
ISTA Pharmaceuticals Receives FDA Approval for Bromday (bromfenac)
Norethindrone- Ethinyl Estradiol- Ferrous Fumarate
Warner Chilcott Announces FDA Approval of New Oral Contraceptive Lo Loestrin Fe (norethindrone acetate and ethinyl estradiol tablets, ethinyl estradiol tablets and ferrous fumarate)
Dasatinib
FDA approves additional medical indication for Sprycel (dasatinib)
Lurasidone
FDA approves Latuda (lurasidone) to treat schizophrenia in adults
Dextromethorphan And Quinidine
Avanir Pharmaceuticals Announces FDA Approval of Nuedexta (dextromethorphan and quinidine)
Ceftaroline Fosamil Injection
FDA Approves Teflaro (ceftaroline fosamil) for Bacterial Infections
Everolimus
FDA Approves New Indication for Afinitor (everolimus)

November
Acetaminophen
Cadence Pharmaceuticals Announces FDA Approval of Ofirmev (acetaminophen) injection for the Management of Pain and Fever
Duloxetine
FDA Clears Cymbalta (duloxetine) to Treat Chronic Musculoskeletal Pain
Saxagliptin And Metformin
Kombiglyze XR (Saxagliptin and Metformin HCl Extended-Release) Tablets Approved in the U.S. for the Treatment of Type 2 Diabetes Mellitus in Adults
Tesamorelin
FDA Approves Egrifta (tesamorelin for injection): First and Only Treatment for the Reduction of Excess Abdominal Fat in HIV-infected Patients with Lipodystrophy
Lisdexamfetamine
FDA Approves Vyvanse (lisdexamfetamine dimesylate) Capsules CII for the Treatment of ADHD in Adolescents
Eribulin Mesylate
FDA Approves Halaven (eribulin mesylate) for Late-Stage Breast Cancer
Denosumab
FDA Approves Amgen's Xgeva (denosumab) for the Prevention of Skeletal-Related Events in Patients with Bone Metastases from Solid Tumors
Amiodarone
Prism Pharmaceuticals Receives FDA Approval of Ready-to-Use Nexterone (Amiodarone HCl) Premixed Injection
Moxifloxacin
FDA Approves Moxeza (moxifloxacin) for Bacterial Conjunctivitis
Baclofen
FDA Approves Movement Disorder Drug from CNS Therapeutics: Gablofen (Baclofen Injection) for the Treatment of Severe Spasticity
Testosterone
Lilly and Acrux Receive FDA Approval for Axiron (Testosterone) Topical Solution CIII

December
Daptomycin
Cubist Pharmaceuticals Receives FDA Approval for 2-Minute IV Injection of Cubicin (daptomycin )
Darunavir
FDA Approves Prezista (darunavir) Once-Daily Dosing for HIV-1 Treatment-Experienced Adults With No Darunavir Resistance-Associated Mutations
Aliskiren, Amlodipine And Hydrochlorothiazide
Novartis Gains FDA Approval for Amturnide (aliskiren, amlodipine and hydrochlorothiazide), a Triple-Combination Pill to Treat High Blood Pressure in Patients Uncontrolled on Two Medications
Testosterone
Endo Pharmaceuticals Receives FDA Approval for Fortesta (Testosterone) Gel as a Class III Product for Topical Use for Men With Low Testosterone

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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