Posted by Michael Wonder on 04 Mar 2020
Zosano Pharma announces FDA acceptance of 505(b)(2) new drug application for Qtrypta for the acute treatment of migraine
4 March 2020 - Zosano Pharma today announced that the U.S. FDA has accepted the company’s new drug application for Qtrypta for filing and substantive review.
The Prescription Drug User Fee Act goal date for the completion of the FDA’s review of Qtrypta is set for 20 October 2020. This date reflects a standard 10-month review period and is consistent with the review timeline for a 505(b)(2) submission.
Qtrypta is Zosano’s proprietary formulation of zolmitriptan delivered utilising its proprietary intracutaneous microneedle system in development for the acute treatment of migraine.
