Posted by Michael Wonder on 21 Oct 2020
Zosano Pharma receives complete response letter from FDA for Qtrypta
21 October 2020 - FDA feedback consistent with FDA’s preliminary communication in September.
Zosano Pharma announced today that it has received a complete response letter from the U.S. FDA in connection with the Qtrypta (zolmitriptan transdermal microneedle system) new drug application.
The letter cited inconsistent zolmitriptan exposure levels observed across clinical pharmacology studies, which had been previously identified in the FDA’s discipline review letter in September.
