Browse the FDA Approved Drugs by Year

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Browse 2010 FDA Approved Drugs by Month

January February March April May June July August September October November December

January

Dalfampridine

FDA Approves Ampyra (dalfampridine)to Improve Walking in Adults with Multiple Sclerosis

Darunavir

U.S. Food and Drug Administration Approves Labeling Update for Prezista (darunavir) To Include 96-Week Data in HIV-1 Infected Adult Patients

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

Lapatinib

GSK's Tykerb (lapatinib ditosylate) Receives Accelerated Approval for First-Line Combination Treatment of Metastatic Breast Cancer

Liraglutide [rDNA] Injection

FDA Approves Novo-Nordisk's Diabetes Drug Victoza (liraglutide)

Tocilizumab Injection

FDA Approves Actemra (tocilizumab) for the Treatment of Moderately to Severely Active Rheumatoid Arthritis

February

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

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

Meningococcal Conjugate Vaccine

Novartis Gets US Approval for Menveo (meningococcal conjugate vaccine) Meningitis Vaccine

Olmesartan

FDA Approves Benicar (olmesartan medoxomil) for the Treatment of High Blood Pressure in Children and Adolescents aged 6-16

Pneumococcal Vaccine Polyvalent

FDA Approves Prevnar 13 (pneumococcal 13-valent conjugate vaccine) Pneumococcal Disease Vaccine

Pneumococcal Vaccine Polyvalent

FDA Expands Use of Prevnar 13 (pneumococcal 13-valent conjugate vaccine)Vaccine for People Ages 50 and Older

Ritonavir

Abbott Receives U.S. FDA Approval for Heat-Stable Norvir (ritonavir) Tablets

Rituximab

FDA Approves Rituxan (rituximab) to Treat Chronic Lymphocytic Leukemia

Rosuvastatin

FDA Approves Crestor (rosuvastatin calcium) to Reduce Stroke, Heart Attack Risk

Trazodone

Labopharm Receives FDA Approval for Oleptro (trazodone)

Velaglucerase Alfa for Injection

FDA Approves VPRIV (velaglucerase alfa) to Treat Gaucher Disease

March

Adapalene

Galderma Received FDA Approval of Differin (adapalene) Lotion, 0.1%, the First Retinoid Available in Lotion Formulation

Carglumic Acid

FDA Approves Carbaglu to Treat Condition That Causes Elevated Ammonia Levels

Decitabine

FDA Approves Five-Day Dosing Regimen for Dacogen (decitabine) for Injection, Offering a New Outpatient Dosing Option for Myelodysplastic Syndromes (MDS)

Doxepin

Somaxon Announces FDA Approval of Silenor (doxepin) for the Treatment of Insomnia

Hydromorphone

FDA Approves Exaglo (hydromorphone HCl) Extended-Release Tablets

Imiquimod

FDA Approves Zyclara (imiquimod) Cream, 3.75% for the Treatment of Actinic Keratoses

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

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

Polidocanol Injection

FDA Approves Asclera to Treat Small Varicose Veins

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

Somatropin

Novo Nordisk Receives FDA Approval for Norditropin FlexPro for Growth Hormone Treatment

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

April

Erlotinib

FDA Approves Tarceva (erlotinib) as a Maintenance Therapy for Advanced Non-Small Cell Lung Cancer

Everolimus

Novartis Receives US FDA Approval for Zortress (everolimus) to Prevent Organ Rejection in Adult Kidney Transplant Recipients

Immune globulin intravenous

CSL Behring Receives FDA Approval to Extend Shelf Life for Privigen (immune globulin intravenous (human)) from 24 to 36 Months

Lopinavir And Ritonavir

Abbott Receives FDA Approval for Once-Daily Dosing of Kaletra (lopinavir / ritonavir) for Treatment-Experienced Patients

Miconazole

FDA Approves Oravig (miconazole) Buccal Tablets for Treatment of Oropharyngeal Candidiasis

Naproxen And Esomeprazole Magnesium

FDA Approved Vimovo for Arthritis Patients At Risk of Developing NSAID-Associated Gastric Ulcers

Oxycodone Hydrochloride

FDA Approves New Formulation for OxyContin (oxycodone)

Pancrelipase

FDA Approves Pancreatic Enzyme Product, Pancreaze (pancrelipase)

Sipuleucel-T Suspension

FDA Approves Provenge (sipuleucel-T) - a Cellular Immunotherapy for Men With Advanced Prostate Cancer

May

Alglucosidase

FDA Approves Lumizyme (alglucosidase alfa) for Late-Onset Pompe Disease

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

Hexaminolevulinate Hydrochloride

Cysview (Hexaminolevulinate HCl) Approved by the FDA for Cystoscopic Detection of Papillary Bladder Cancer

Pancrelipase

Abbott Receives FDA Approval for Creon (pancrelipase) to Include Dosing Information for Patients With Chronic Pancreatitis and Pancreatectomy

June

Buprenorphine

Purdue Pharma L.P. Receives FDA Approval for Butrans (buprenorphine) Transdermal System CIII

Cabazitaxel

Jevtana (cabazitaxel) Injection Approved by U.S. FDA After Priority Review

Denosumab

FDA Approves Amgen's Prolia (Denosumab) for Treatment of Postmenopausal Women With Osteoporosis at High Risk for Fracture

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

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

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

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

Nilotinib

Novartis International AG (CH) - FDA approves Tasigna (nilotinib) for newly diagnosed chronic myeloid leukemia patients, data demonstrate major advance over Glivec

Ranibizumab

FDA Approves Lucentis (Ranibizumab Injection) for the Treatment of Macular Edema Following Retinal Vein Occlusion

Sumatriptan

FDA Approves Alsuma (sumatriptan) Auto-Injector

Vardenafil

FDA approves Staxyn (vardenafil HCl) orally disintegrating tablets for erectile dysfunction (ED)

July

Alcaftadine Ophthalmic Solution

FDA Approves Lastacaft (alcaftadine ophthalmic solution) for Prevention of Itching Associated with Allergic Conjunctivitis

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

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

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

Glycopyrolate

FDA Approves Cuvposa (glycopyrrolate) for Chronic Drooling in Children

Interferon Alfacon-1

Three Rivers Pharmaceuticals Announces FDA Approval Of Expanded Labeling of Infergen (interferon alfacon-1)

Methylphenidate

FDA Approves Daytrana (methylphenidate transdermal system) CII for the Treatment of ADHD in Adolescents

Niacin Er And Simvastatin

Abbott's Simcor (niacin extended-release/simvastatin) Receives FDA Approval for New Dosage Strengths

Ondansetron

FDA Approves Strativa Pharmaceuticals' Zuplenz (ondansetron) Oral Soluble Film

August

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

Ulipristal Acetate

FDA Approves ella (ulipristal acetate) Tablets for Prescription Emergency Contraception

Valganciclovir

FDA Approves Longer Use of Valcyte (valganciclovir) for Adult Kidney Transplant Patients at High Risk of Developing Cytomegalovirus (CMV) Disease

September

Asenapine

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

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

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

Dexamethasone Ophthalmic

Allergan Receives FDA Approval for Ozurdex (dexamethasone) as Treatment Option for Non-Infectious Uveitis Affecting the Posterior Segment of the Eye

Fingolimod

Novartis Gains FDA Approval For Gilenya (fingolimod), A Novel First-Line Multiple Sclerosis Treatment Shown To Significantly Reduce Relapses And Delay Disability Progression

Fulvestrant

FDA Approves New Dosing for Faslodex (fulvestrant) Injection in Treatment of Metastatic Breast Cancer in HR+ Postmenopausal Women

Pegloticase

FDA Approves Krystexxa (pegloticase) for Gout

Pralidoxime

FDA Approves Pediatric Use of Protopam Chloride (pralidoxime chloride) Chemical Poisoning Treatment

October

Bromfenac Ophthalmic Solution

ISTA Pharmaceuticals Receives FDA Approval for Bromday (bromfenac)

Calcipotriene

Stiefel, a GSK company, Receives FDA Approval of Sorilux (calcipotriene) Foam, 0.005%

Ceftaroline Fosamil Injection

FDA Approves Teflaro (ceftaroline fosamil) for Bacterial Infections

Corticotropin

FDA Approves H.P. Acthar Gel (corticotropin) for the Treatment of Infantile Spasms

Dabigatran

FDA Approves Pradaxa (dabigatran etexilate) to Prevent Stroke in People With Atrial Fibrillation

Dasatinib

FDA approves additional medical indication for Sprycel (dasatinib)

Dextromethorphan And Quinidine

Avanir Pharmaceuticals Announces FDA Approval of Nuedexta (dextromethorphan and quinidine)

Entecavir

U.S. Food and Drug Administration Approves Baraclude (entecavir) as a Treatment for Chronic Hepatitis B Patients with Evidence of Decompensated Liver Disease

Everolimus

FDA Approves New Indication for Afinitor (everolimus)

Immune Globulin Intravenous And Subcutaneous

Talecris Biotherapeutics Receives FDA Approval for Gamunex-C (immune globulin intravenous and subcutaneous)

Lurasidone

FDA approves Latuda (lurasidone) to treat schizophrenia in adults

Mannitol

United States Food and Drug Administration Approves Aridol (mannitol)

Naltrexone

FDA Approves Vivitrol (naltrexone) to Treat Opioid-dependent Patients

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)

Risedronate

Warner Chilcott Announces FDA Approval of Atelvia (risedronate sodium) Next Generation Actonel

November

Acetaminophen

Cadence Pharmaceuticals Announces FDA Approval of Ofirmev (acetaminophen) injection for the Management of Pain and Fever

Amiodarone

Prism Pharmaceuticals Receives FDA Approval of Ready-to-Use Nexterone (Amiodarone HCl) Premixed Injection

Baclofen

FDA Approves Movement Disorder Drug from CNS Therapeutics: Gablofen (Baclofen Injection) for the Treatment of Severe Spasticity

Denosumab

FDA Approves Amgen's Xgeva (denosumab) for the Prevention of Skeletal-Related Events in Patients with Bone Metastases from Solid Tumors

Duloxetine

FDA Clears Cymbalta (duloxetine) to Treat Chronic Musculoskeletal Pain

Eribulin Mesylate

FDA Approves Halaven (eribulin mesylate) for Late-Stage Breast Cancer

Lisdexamfetamine

FDA Approves Vyvanse (lisdexamfetamine dimesylate) Capsules CII for the Treatment of ADHD in Adolescents

Moxifloxacin

FDA Approves Moxeza (moxifloxacin) for Bacterial Conjunctivitis

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