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)
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