Agile Therapeutics Announces FDA Advisory Committee Meeting for its Investigational Transdermal Low-Dose Contraceptive Patch, Twirla® (AG200-15)
Agile Therapeutics, Inc. (AGRX)
Last agile therapeutics, inc. earnings: 5/2 04:15 pm
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US:NASDAQ Investor Relations:
ir.agiletherapeutics.com/investor-relations
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Source: GlobeNewswire
Meeting Scheduled for October 30, 2019 FDA Previously Assigned PDUFA (Prescription Drug User Fee Act) Goal Date is November 16, 2019 PRINCETON, N.J., June 24, 2019 (GLOBE NEWSWIRE) -- Agile Therapeutics, Inc. (Nasdaq: AGRX), a women’s healthcare company, today announced that a meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) has been scheduled for October 30, 2019, to review the Company’s New Drug Application (NDA) for its lead product candidate, Twirla® (AG200-15), an investigational low-dose combined hormonal contraceptive patch. Agile resubmitted the NDA for Twirla (AG200-15) on May 16, 2019, and the FDA has assigned a PDUFA (Prescription Drug User Fee Act) goal date of November 16, 2019, for the completion of its review of the Twirla (AG200-15) NDA. “We look forward to the October 30, 2019, meeting with the Advisory Committee, as well as to continuing our dialogue with the FDA about Twirla and the im
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