20 December 2019 - Evoke Pharma today announced that it has resubmitted 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.

The application for Gimoti was resubmitted based on feedback received during the Type A meeting with FDA in July 2019. The meeting was held to obtain feedback and agreement on the items cited as deficiencies in the Complete Response Letter (CRL) issued by FDA in April 2019. 

In the CRL, FDA stated the application was not approvable as originally submitted and provided recommendations to address approvability issues related to clinical pharmacology and product quality/device quality.

Read Evoke Pharma press release