Agile Therapeutics Announces FDA Extension of Twirla® NDA Review Period
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
PRINCETON, N.J., Nov. 14, 2019 (GLOBE NEWSWIRE) -- Agile Therapeutics, Inc. (Nasdaq: AGRX), a women’s healthcare company, today announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) goal date for its review of the New Drug Application (NDA) of Twirla® (levonorgestrel/ethinyl estradiol) transdermal system, an investigational combined hormonal contraceptive patch, from November 16, 2019 to February 16, 2020. On October 30, 2019, the FDA’s Bone, Reproductive, and Urologic Drugs Advisory Committee (BRUDAC) met to discuss the benefits and risks of Twirla and voted 14 to 1, with one abstention, that the benefits of Twirla (AG200-15) in the prevention of pregnancy outweigh the risks to support approval. Although the FDA considers the non-binding recommendation of this panel, the final decision regarding the approval of the product is made by the FDA alone. After the BRUDAC meeting, at the FDA’s request, Agile submitted additio
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- Agile Therapeutics Inc. Announces Completion of Acquisition by Insud Pharma, S.L.GlobeNewswire
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Sec Filings
- 8/26/24 - Form 4
- 8/26/24 - Form 4
- 8/26/24 - Form 4
- AGRX's page on the SEC website