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Gimoti FDA Approval History

Last updated by Judith Stewart, BPharm on Jan 27, 2021.

FDA Approved: Yes (First approved June 19, 2020)
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 for the relief of symptoms of acute and recurrent diabetic gastroparesis in adults.

Development timeline for Gimoti

Jun 19, 2020Approval FDA Approves Gimoti (metoclopramide) Nasal Spray for Diabetic Gastroparesis
Jan 21, 2020FDA Accepts Evoke Pharma’s NDA Resubmission for Gimoti
Dec 20, 2019Evoke Resubmits Gimoti New Drug Application to FDA
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

Further information

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