Agile Therapeutics Inc.'s hormonal contraceptive patch, Twirla, was not approved by the U.S. Food and Drug Administration.
In a complete response letter, the FDA determined that it cannot approve the new drug application in its present form. The FDA identified quality adhesion test method issues and said the observations on the company's third-party manufacturing sites must be resolved.
A new drug application was resubmitted in June after the previous application was rejected in February 2013. Agile reported results from a January phase 3 trial that addressed issues raised by the U.S. FDA in 2013.
The company submitted an amendment to the application on Dec. 1 including a response to the quality adhesion test methods information request by the FDA and to the facility inspection observations. The FDA said the amendment was not reviewed prior to the FDA's action. The FDA said the amendment would be incorporated when responding to the deficiencies outlined in the complete response letter.
