Recent And Upcoming FDA Advisory Committee Meetings
Executive Summary
Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.
Topics | Advisory Committee | Date | Details |
Continued approval of AMAG's Makena (hydroxyprogesterone caproate injection) for reducing the risk of preterm birth in light of the failed confirmatory study |
Bone, Reproductive and Urologic Drugs |
Oct. 29 |
(Also see "AMAG’s Explanation For Makena's Failed Confirmatory Trial Faces Skeptical US FDA" - Pink Sheet, 27 Oct, 2019.) |
Agile Therapeutics' Twirla (levonorgestrel and ethinyl estradiol transdermal system) for the prevention of pregnancy in women of reproductive potential |
Bone, Reproductive and Urologic Drugs |
Oct. 30 |
|
Development of chikungunya vaccines |
Vaccines and Related Biological Products |
Nov. 8 |
|
Boehringer Ingelheim's Jardiance (empagliflozin) as an adjunct to insulin therapy to improve glycemic control in adults with type 1 diabetes mellitus |
Endocrinologic and Metabolic Drugs |
Nov. 13 |
|
Amarin's Vascepa (icosapent ethyl) to reduce the risk of cardiovascular events, as an adjunct to statin therapy, in adults with elevated triglyceride levels (135 mg/dL or greater) and other risk factors for CV disease |
Endocrinologic and Metabolic Drugs |
Nov. 14 |
(Also see "Vascepa Advisory Committee Is Latest Outpost In Product's Remarkable Regulatory Journey" - Pink Sheet, 11 Sep, 2019.) |