U.S. FDA New Drug and Product Approvals Document List

List of FDA Approvals Publications:

• 1 - Safety and Effectiveness of Consumer Hand Sanitizers : U.S. Food and Drug Administration (2019/04/11)
• 2 - Generic Version of EpiPen Approved by U.S. FDA : U.S. Food and Drug Administration (2018/08/19)
• 3 - Scammers Target Consumers with Fake FDA Warning Letters : U.S. Food and Drug Administration (2018/07/13)
• 4 - FDA Approves Glucose Monitoring System with Sensor and App for Adults with Diabetes : U.S. Food and Drug Administration (FDA) (2018/06/21)
• 5 - Automated Insulin Delivery and Monitoring System for Younger Pediatric Patients Approved by FDA : U.S. Food and Drug Administration (FDA) (2018/06/21)
• 6 - US FDA Authorizes First Fully Interoperable Continuous Glucose Monitoring System : U.S. Food and Drug Administration (2018/03/29)
• 7 - Statement From FDA Commissioner on Steps to Facilitate Efficient Generic Drug Review to Enhance Competition, Promote Access and Lower Drug Prices : U.S. FDA (2018/01/03)
• 8 - FDA Permits Marketing of Device to Treat Diabetic Foot Ulcers : U.S. Food and Drug Administration (2017/12/28)
• 9 - U.S. FDA Approves Gene Therapy for Treatment of Cancer and Life-threatening Diseases : U.S. Food and Drug Administration (2017/09/22)
• 10 - U.S. FDA Approves Radicava (Edaravone) to Treat ALS : U.S. Food and Drug Administration (2017/05/06)
• 11 - U.S. FDA Approves Ocrevus (Ocrelizumab) to Treat Multiple Sclerosis : U.S. Food and Drug Administration (FDA) (2017/03/30)
• 12 - Researchers Urge More Transparency From FDA : Johns Hopkins University Bloomberg School of Public Health (2017/03/18)
• 13 - FDA Approves Noctiva for Frequent Night Urination Treatment : U.S. Food and Drug Administration (2017/03/07)
• 14 - FDA Approves Emflaza (Deflazacort) to Treat Duchenne Muscular Dystrophy : U.S. Food and Drug Administration (FDA) (2017/02/09)
• 15 - Lawsuit Urges FDA to Protect Hair Salon Workers and Consumers from Formaldehyde : Environmental Working Group (2016/12/14)
• 16 - FDA Approves First Drug to Treat Duchenne Muscular Dystrophy : U.S. FDA (2016/09/20)
• 17 - FDA Challenged to Support Claims Regarding Electronic Cigarettes : E-Cigarette Reviewed (2013/02/20)
• 18 - Ethical Dilemmas Contribute to Weakness in FDA Postmarket Oversight : Johns Hopkins Medicine (2012/08/23)
• 19 - Insomnia Drug Intermezzo Approved by FDA : U.S. Food and Drug Administration (2011/11/25)
• 20 - Cialis to Treat Benign Prostatic Hyperplasia Approved by FDA : U.S. Food and Drug Administration (2011/10/13)
• 21 - Boostrix for Tetanus, Diphtheria and Pertussis in Seniors : U.S. Food and Drug Administration (2011/07/10)
• 22 - FDA Approves Lazanda (Fentanyl) Nasal Spray for Breakthrough Cancer Pain : Archimedes Pharma Ltd. (2011/06/30)
• 23 - Global Strategy to Help Ensure Safety and Quality of Imported Products : U.S. Food and Drug Administration (2011/06/20)
• 24 - Injectable Gel to Treat Fecal Incontinence Approved by FDA : U.S. Food and Drug Administration (2011/05/28)
• 25 - Toxoplasmosis Parasite Infection Test : U.S. Food and Drug Administration (2011/05/24)
• 26 - Sutent for Rare Type of Pancreatic Cancer Approved by FDA : U.S. Food and Drug Administration (2011/05/22)
• 27 - Q Fever Test for Military Personnel Serving Overseas : U.S. Food and Drug Administration (2011/05/22)
• 28 - Edurant a New HIV Treatment Approved by FDA : U.S. Food and Drug Administration (2011/05/20)
• 29 - FDA Approves Victrelis for Hepatitis C : U.S. Food and Drug Administration (2011/05/14)
• 30 - FDA Approves Tradjenta (linagliptin) for Treatment of Type 2 Diabetes : FDA Approvals (2011/05/03)
• 31 - Horizant for Restless Legs Syndrome FDA Approved : U.S. Food and Drug Administration (2011/04/10)
• 32 - FDA Proposes Draft Menu and Vending Machine Labeling Requirements : U.S. Food and Drug Administration (2011/04/01)
• 33 - Treatment for a Late Stage Skin Cancer : U.S. Food and Drug Administration (2011/03/28)
• 34 - Zostavax Vaccine to Prevent Shingles - FDA Approval : U.S. Food and Drug Administration (2011/03/25)
• 35 - Edarbi for High Blood Pressure Approved by FDA : U.S. Food and Drug Administration (2011/02/26)
• 36 - Neuralstem Receives FDA Orphan Designation for Spinal Cord Stem Cells for Treatment of ALS : Neuralstem, Inc. (2011/02/14)
• 37 - FDA Approves Viibryd to Treat Major Depressive Disorder : U.S. Food and Drug Administration (2011/01/22)
• 38 - Natroba (Spinosad) Head Lice Treatment for Children and Adults - FDA Approval : U.S. Food and Drug Administration (2011/01/18)
• 39 - FDA Warns Consumers Not to Use Fruta Planta Weight Loss Products : FDA (2011/01/01)
• 40 - FDA Approval for Axiron (testosterone) Topical Solution CIII : Health News (2010/11/27)
• 41 - Extension of FDA Review for Cladribine Tablets for Treatment of Relapsing Forms of Multiple Sclerosis : EMD Serono, Inc. (2010/11/26)
• 42 - FDA Approves Cymbalta for Chronic Musculoskeletal Pain : Eli Lilly and Company (2010/11/07)
• 43 - FDA Approval of First Drug to Treat Tuberous Sclerosis Complex : Tuberous Sclerosis Alliance (2010/10/30)
• 44 - PRADAX Approved for for Stroke Prevention in Canadians with Atrial Fibrillation : BOEHRINGER INGELHEIM (2010/10/27)
• 45 - New Oral Contraceptive Also Raises Folate Levels : Bayer HealthCare Pharmaceuticals Inc. (2010/09/25)
• 46 - Oral Drug to Reduce MS Relapses FDA Approved : U.S. Food and Drug Administration (2010/09/22)
• 47 - FDA Approves New Drug for Gout : U.S. Food and Drug Administration (2010/09/15)
• 48 - FDA Approves Pediatric Use of Chemical Poisoning Treatment : U.S. Food and Drug Administration (2010/09/09)
• 49 - Actavis Receives FDA Approval of Atomoxetine HCl Capsules for ADHD : Actavis Inc. (2010/09/02)
• 50 - FDA Approves New Abortion Drug Ella as Emergency Contraceptive : Family Research Council (2010/08/15)
• 51 - Public Outcry for FDA Reform : DeLuca & Weizenbaum, Ltd. (2010/08/13)
• 52 - FDA Approves Vaccines for 2010-2011 Influenza Season : U.S. Food and Drug Administration (2010/07/31)
• 53 - New York State Approves Quest Diagnostics Fragile X Syndrome Test : Quest Diagnostics (2010/07/30)
• 54 - Implantable Miniature Telescope Improves Sight of AMD Patients : U.S. Food and Drug Administration (2010/07/08)
• 55 - Circadin Approved in EU for Treatment of Primary Insomnia : Neurim Pharmaceuticals LTD (2010/07/05)
• 56 - FDA Approves New Treatment for Advanced Prostate Cancer : U.S. Food and Drug Administration (2010/06/18)
• 57 - FDA Clearance of Lactate Test : Epocal, Inc. (2010/06/15)
• 58 - FDA Advisory Committee Recommends Approval of FTY720 Fingolimod for Relapsing Remitting Multiple Sclerosis : Novartis Pharmaceuticals Corporation (2010/06/12)
• 59 - FDA to Review Dental Amalgam : U.S. Food and Drug Administration (2010/06/10)
• 60 - FDA Approves New Injectable Osteoporosis Treatment for Postmenopausal Women : U.S. Food and Drug Administration (2010/06/01)
• 61 - LensAR Laser System Receives FDA Clearance for Use in Cataract Surgery : LensAR, Inc. (2010/05/18)
• 62 - FDA Clearance for Redsense Safety Device for Home use During Home Hemodialysis : Redsense Medical AB (2010/05/18)
• 63 - Equal Rigor in Assessing Food Claims and Drug Approvals : DW (2010/05/12)
• 64 - U.S. FDA Approves Natazia, a New Oral Contraceptive for the Prevention of Pregnancy : Bayer HealthCare Pharmaceuticals Inc. (2010/05/08)
• 65 - FDA Approved VIMOVO for Arthritis Patients : FDA Approvals (2010/05/03)
• 66 - FDA Approval of Asclera to Treat Varicose Veins : Merz Aesthetics (2010/04/24)
• 67 - Device Manufacturers to Include Information on Pediatric Populations : U.S. Food and Drug Administration (2010/03/31)
• 68 - Once-Daily MIRAPEX ER Approved by FDA for Parkinson's Disease : Boehringer Ingelheim Pharmaceuticals, Inc. (2010/03/23)
• 69 - FDA Approval of Differin (adapalene) Lotion for Acne Treatment : Galderma Laboratories, L.P. (2010/03/22)