December 22, 2017 / 12:46 PM / 2 years ago

FDA declines to approve Agile's contraceptive patch

Dec 22 (Reuters) - Agile Therapeutics Inc said on Friday the U.S. Food and Drug Administration declined to approve the company’s contraceptive patch, citing deficiencies related to its adhesion test methods.

The health regulator also said that the company would have to resolve the observations found during inspection of third-party manufacturing facility, Corium International Inc .

Agile’s once-weekly, low-dose contraceptive patch, Twirla, is a combination hormonal patch that contains ethinyl estradiol and levonorgestrel. (Reporting by Divya Grover in Bengaluru; Editing by Anil D’Silva)

0 : 0
  • narrow-browser-and-phone
  • medium-browser-and-portrait-tablet
  • landscape-tablet
  • medium-wide-browser
  • wide-browser-and-larger
  • medium-browser-and-landscape-tablet
  • medium-wide-browser-and-larger
  • above-phone
  • portrait-tablet-and-above
  • above-portrait-tablet
  • landscape-tablet-and-above
  • landscape-tablet-and-medium-wide-browser
  • portrait-tablet-and-below
  • landscape-tablet-and-below