Gimoti Approval Status
FDA Approved: No
Brand name: Gimoti
Generic name: metoclopramide
Dosage form: Nasal Spray
Company: Evoke Pharma, Inc.
Treatment for: Gastroparesis
Gimoti (metoclopramide) is an intranasal formulation of the approved drug metoclopramide in development for the treatment of symptoms associated with diabetic gastroparesis in women.
Development Status and FDA Approval Process for Gimoti
|Apr 2, 2019||Evoke Pharma Receives Complete Response Letter and Recommendations to Address Deficiencies from FDA for Gimoti NDA|
|Mar 14, 2019||Evoke Pharma Submits Response to FDA Review Letter for Gimoti NDA|
|Aug 16, 2018||Evoke Pharma’s Gimoti NDA Accepted for FDA Review|
|Jun 4, 2018||Evoke Announces FDA Submission of New Drug Application for Gimoti|
|Mar 5, 2018||FDA Approves PDUFA Fee Waiver for Gimoti New Drug Application|
|Oct 13, 2017||Evoke Pharma Announces Positive Topline Results from Comparative Exposure Pharmacokinetic Study for Gimoti|
|May 10, 2017||Evoke Pharma Presents Gimoti Efficacy and Safety Data from Phase 3 Trial as Late Breaker at Digestive Disease Week 2017|
|Apr 18, 2017||Evoke Pharma Announces Collaboration with Spaulding Clinical Research for the Gimoti Comparative Exposure Pharmacokinetic Trial|
|Apr 4, 2017||Positive Type A Meeting with FDA Confirms Acceptability of Evoke Pharma's Proposed Comparative Exposure PK Trial for Gimoti NDA|
|Dec 15, 2016||Evoke Receives Positive NDA Submission Guidance from US FDA for Gimoti|
|Sep 7, 2016||Evoke Pharma Announces Positive Non-Clinical Pre-NDA Meeting with FDA for Gimoti|
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