| January | February | March | April |
| May | June | July | August |
| September | October | November | December |
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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 |
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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) |
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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 |
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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 |
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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 |
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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 |
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Rituximab
FDA Approves Rituxan (rituximab) to Treat Chronic Lymphocytic Leukemia |
Meningococcal Conjugate Vaccine
Novartis Gets US Approval for Menveo (meningococcal conjugate vaccine) Meningitis Vaccine |
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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 |
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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 |
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Hydromorphone
FDA Approves Exaglo (hydromorphone HCl) Extended-Release Tablets |
Somatropin
Novo Nordisk Receives FDA Approval for Norditropin FlexPro for Growth Hormone Treatment |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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Imiquimod
FDA Approves Zyclara (imiquimod) Cream, 2.5% for the Treatment of Actinic Keratoses |
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Oxycodone Hydrochloride
FDA Approves New Formulation for OxyContin (oxycodone) |
Pancrelipase
FDA Approves Pancreatic Enzyme Product, Pancreaze (pancrelipase) |
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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 |
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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 |
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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 |
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Naproxen And Esomeprazole Magnesium
FDA Approved Vimovo for Arthritis Patients At Risk of Developing NSAID-Associated Gastric Ulcers |
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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 |
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Gatifloxacin
Allergan Receives FDA Approval for Zymaxid (gatifloxacin) Ophthalmic Solution |
Alglucosidase
FDA Approves Lumizyme (alglucosidase alfa) for Late-Onset Pompe Disease |
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Hexaminolevulinate Hydrochloride
Cysview (Hexaminolevulinate HCl) Approved by the FDA for Cystoscopic Detection of Papillary Bladder Cancer |
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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 |
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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) |
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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 |
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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 |
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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 |
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Denosumab
FDA Approves Amgen's Prolia (Denosumab) for Treatment of Postmenopausal Women With Osteoporosis at High Risk for Fracture |
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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) |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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Pegloticase
FDA Approves Krystexxa (pegloticase) for Gout |
Asenapine
Merck Receives Approval from FDA for Expanded Indications for Atypical Antipsychotic Medication Saphris (asenapine) Sublingual Tablets |
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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 |
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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 |
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Mannitol
United States Food and Drug Administration Approves Aridol (mannitol) |
Risedronate
Warner Chilcott Announces FDA Approval of Atelvia (risedronate sodium) Next Generation Actonel |
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Calcipotriene
Stiefel, a GSK company, Receives FDA Approval of Sorilux (calcipotriene) Foam, 0.005% |
Naltrexone
FDA Approves Vivitrol (naltrexone) to Treat Opioid-dependent Patients |
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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 |
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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 |
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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) |
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Dasatinib
FDA approves additional medical indication for Sprycel (dasatinib) |
Lurasidone
FDA approves Latuda (lurasidone) to treat schizophrenia in adults |
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Dextromethorphan And Quinidine
Avanir Pharmaceuticals Announces FDA Approval of Nuedexta (dextromethorphan and quinidine) |
Ceftaroline Fosamil Injection
FDA Approves Teflaro (ceftaroline fosamil) for Bacterial Infections |
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Everolimus
FDA Approves New Indication for Afinitor (everolimus) |
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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 |
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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 |
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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 |
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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 |
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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 |
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Testosterone
Lilly and Acrux Receive FDA Approval for Axiron (Testosterone) Topical Solution CIII |
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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 |
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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 |