Posted by Michael Wonder on 22 Jan 2020
FDA accepts Evoke Pharma’s NDA resubmission for Gimoti
21 January 2020 - PDUFA Target Goal Date is 19 June 2020.
Evoke Pharma today announced that the U.S. FDA has accepted the Company’s resubmission of its new drug application for Gimoti, the Company’s nasal spray product candidate for the relief of symptoms in adult women with acute and recurrent diabetic gastroparesis.
A six-month period of review from the FDA’s date of receipt has been assigned for the resubmitted application and the application has been assigned a new Prescription Drug User Fee Act target goal date of 19 June 2020.
