Posted by Michael Wonder on 05 Jun 2018
Evoke announces FDA submission of new drug application for Gimoti
4 June 2018 - Evoke Pharma today announced the submission of its 505(b)(2) new drug application to the U.S. FDA for Gimoti, the Company’s nasal spray product candidate for the relief of symptoms in adult women with acute and recurrent diabetic gastroparesis.
Based on FDA timelines for review of the initial NDA submission, and Evoke’s NDA submission on 1 June 2018, the Company expects to receive notification from FDA the filing was accepted for substantive review in early August 2018.
