Recent And Upcoming FDA Advisory Committee Meetings

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	Meeting notice (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	Meeting notice
Development of chikungunya vaccines	Vaccines and Related Biological Products	Nov. 8	Meeting notice
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	Meeting notice
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	Meeting notice (Also see "Vascepa Advisory Committee Is Latest Outpost In Product's Remarkable Regulatory Journey" - Pink Sheet, 11 Sep, 2019.)