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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

DateArticle
Apr  2, 2019Evoke Pharma Receives Complete Response Letter and Recommendations to Address Deficiencies from FDA for Gimoti NDA
Mar 14, 2019Evoke Pharma Submits Response to FDA Review Letter for Gimoti NDA
Aug 16, 2018Evoke Pharma’s Gimoti NDA Accepted for FDA Review
Jun  4, 2018Evoke Announces FDA Submission of New Drug Application for Gimoti
Mar  5, 2018FDA Approves PDUFA Fee Waiver for Gimoti New Drug Application
Oct 13, 2017Evoke Pharma Announces Positive Topline Results from Comparative Exposure Pharmacokinetic Study for Gimoti
May 10, 2017Evoke Pharma Presents Gimoti Efficacy and Safety Data from Phase 3 Trial as Late Breaker at Digestive Disease Week 2017
Apr 18, 2017Evoke Pharma Announces Collaboration with Spaulding Clinical Research for the Gimoti Comparative Exposure Pharmacokinetic Trial
Apr  4, 2017Positive Type A Meeting with FDA Confirms Acceptability of Evoke Pharma's Proposed Comparative Exposure PK Trial for Gimoti NDA
Dec 15, 2016Evoke Receives Positive NDA Submission Guidance from US FDA for Gimoti
Sep  7, 2016Evoke Pharma Announces Positive Non-Clinical Pre-NDA Meeting with FDA for Gimoti

Further information

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