November 14, 2019 / 9:51 PM / 25 days ago

FDA delays review of Agile's birth control patch by 3 months; shares slide

Nov 14 (Reuters) - The U.S. Food and Drug Administration on Thursday delayed its review of Agile Therapeutics Inc’s hormonal contraceptive patch by three months, sending its shares down 35% after the bell.

Twirla, a once-weekly contraceptive patch made from a combination of hormones ethinyl estradiol and levonorgestrel, was backed by a panel of independent experts last month.

Shares of the drug developer have more than tripled in value after the panel meeting.

The company said the additional information submitted to the agency after the panel meeting was considered as a major amendment to its original marketing application that would require additional time to review.

Agile was denied approval for the patch in 2013 and again in 2017.

The FDA, which was slated to announce its decision on the product by Saturday, will now complete its review of the birth control patch by Feb. 16, the company said.

Reporting by Dania Nadeem and Saumya Sibi Joseph in Bengaluru; Editing by Arun Koyyur

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