Agile Therapeutics Inc (AGRX)

[XenaLives]

Discussion of advisory committee decision, excerpt:

FDA/CDC
FDA advisory committee supports birth control patch approval
Publish date: October 30, 2019
By Heidi Splete

FROM THE FDA

A Food and Drug Administration committee voted 14-1, with one abstaining vote, that the benefits of the investigational contraceptive patch AG200-15 (ethinyl estradiol and levonorgestrel; Twirla) sufficiently outweigh the risks to warrant recommendation of approval.

FDA icon
Most of the committee members based their decisions on the need for additional contraceptive options for patients. However, most also expressed concerns about its efficacy and offered suggestions for product labeling that called attention to high rates of unintended pregnancies and increased risk of venous thromboembolism (VTE) in obese women.

https://www.mdedge.com/internalmedicine/article/211286/womens-health/fda-advisory-committee-supports-birth-control-patch