Posted by Michael Wonder on 22 May 2019
Agile Therapeutics announces FDA acceptance of the NDA resubmission of Twirla
22 May 2019 - FDA assigns Prescription Drug User Fee Act goal date of 16 November 2019.
Agile Therapeutics today announced that the U.S. FDA has accepted for review the Company’s new drug application resubmission for Twirla (AG200-15), an investigational low-dose combined hormonal contraceptive patch.
The NDA resubmission was submitted on May 16, 2019 and is intended to address a Complete Response Letter (CRL) issued by the FDA in December 2017, which identified deficiencies relating to (i) quality control adhesion test methods for the Twirla manufacturing process, (ii) observations identified during an inspection of a facility of our third-party manufacturer for the Twirla NDA that must be resolved, and (iii) questions on the in vivo adhesion properties of Twirla and their potential relationship to the SECURE clinical trial results.
