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# Agile NDA Resubmitted for Contraceptive Patch
- URL: https://www.fdaweb.com/agile-nda-resubmitted-for-contraceptive-patch/
- Published: 2019-05-22T12:00:00.000Z
- Updated: 2026-09-15T01:28:20.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144167

FDA has accepted for review an Agile Therapeutics NDA resubmission for Twirla (ethinyl estradiol and levonorgestrel transdermal system), an investigational low-dose combined hormonal contraceptive patch. The original NDA received a complete response letter 12/2017 that, according to the company, identified deficiencies relating to (**1**) quality control adhesion test methods for the Twirla manufacturing process, (**2**) observations identified during an inspection at its third-party manufacturer, and (**3**) questions on *in vivo* adhesion properties of Twirla and their potential relationship to the SECURE clinical trial results.

The resubmitted NDA includes results from a comparative wear study that was conducted based on an agency request to address the questions about *in vivo* adhesion, Agile says. It also includes additional information on the company’s manufacturing process, and other analyses responding to the 2017 letter.

FDA has determined that the resubmission is complete and it set a review deadline of 11/16.