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FDA’s Office of Drug Evaluation III Denies Agile Therapeutics, Inc.’s Initial Formal Dispute Resolution Request

Agile Therapeutics, Inc (AGRX)  More Company Research Source: GlobeNewswire
Last agile therapeutics, inc earnings: 11/1 04:15 pm Check Earnings Report
US:NASDAQ Investor Relations: ir.agiletherapeutics.com/investor-relations
PDF Company Plans to Appeal to the FDA’s Office of New Drugs PRINCETON, N.J., July 24, 2018 (GLOBE NEWSWIRE) -- Agile Therapeutics, Inc., (Nasdaq:AGRX) (the “Company”), a women’s healthcare company, today announced that the Office Director of the FDA’s Office of Drug Evaluation III (ODEIII) has affirmed the position of the Division of Bone, Reproductive and Urologic Products (DBRUP) and denied the Company’s appeal of the December 21, 2017 Complete Response Letter in relation to the New Drug Application (NDA) for Twirla®. The Company had appealed the decision by DBRUP that concerns surrounding the in vivo adhesion properties of Twirla prevent its approval and cannot be addressed through the Company’s proposed patient compliance programs.  The Company intends to appeal the ODEIII decision to the Office of New Drugs. Agile initiated formal dispute resolution with the FDA’s ODEIII on June 6, 2018 to appeal the December 21, 2017 CRL for Twirla.  The appeal was submitted in accordance with [Read more]

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