Posted by Michael Wonder on 23 Dec 2017
Agile Therapeutics receives a complete response letter from the FDA for Twirla (AG200-15) for the prevention of pregnancy
22 December 2017 - Agile Therapeutics today announced that the U.S. FDA issued a complete response letter in response to the new drug application resubmission for the Company's investigational non-daily, low dose combination hormonal contraceptive patch, Twirla (AG200-15).
The resubmission, which is seeking approval for Twirla was accepted for review earlier this year. The Prescription Drug User Fee Act goal date was 26 December 2017.
The complete response letter states that the FDA has determined that it cannot approve the application in its present form.
