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

FDA Approvals Publications:

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