Agile resubmits NDA for contraceptive patch Twirla; shares up 2%

|About: Agile Therapeutics, Inc. (AGRX)|By:, SA News Editor

Agile Therapeutics (AGRX +1.8%) resubmits its New Drug Application (NDA) to the FDA seeking approval of lead product candidate Twirla, a low-dose combined hormonal contraceptive patch. It received a CRL in February 2013 citing the need for an additional clinical trial and additional information on the manufacturing process.

The company says it expects a six-month review once the agency accepts the filing.

Previously: Agile Therapeutics announces results of its pre-submission meeting with FDA (April 11)

Previously: Agile's "positive" late-stage trial data for contraceptive patch Twirla ain't so positive; shares plummet 74% after hours (Jan. 3)

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