Agile Therapeutics Resubmits New Drug Application

Agile Therapeutics, a women’s healthcare company, said early Tuesday it has resubmitted to the U.S. Food and Drug Administration (FDA) a new drug application (NDA) for its lead product candidate, Twirla, an investigational low-dose combined hormonal contraceptive patch.

Agile resubmitted the NDA in response to a February 2013 complete response letter (CRL) from the FDA, which recommended that Agile conduct a new clinical trial and provide additional information on the manufacturing process for Twirla. The resubmitted NDA includes efficacy and safety data from the new phase 3 clinical trial.

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