Advisory Committee positive for Twirla a combined hormonal contraceptive patch.- Agile Therapeutics
Agile Therapeutics, Inc. announced a positive outcome from the meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee (BRUDAC) of the FDA. The BRUDAC met to discuss the Company�s New Drug Application (NDA) for its lead product candidate, Twirla (AG200-15), an investigational combined hormonal contraceptive patch. The BRUDAC voted 14 to 1, with 1 abstention, that the benefits of Twirla (AG200-15) in the prevention of pregnancy outweigh the risks to support approval.
The FDA has assigned a PDUFA (Prescription Drug User Fee Act) goal date of 16 November 2019, for the completion of its review of the Twirla (AG200-15) NDA.
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