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# Evoke Pharma Plans 505(b)(2) NDA for Nasal Metoclopramide
- URL: https://www.fdaweb.com/evoke-pharma-plans-505-b-2-nda-for-nasal-metoclopramide/
- Published: 2016-09-07T12:00:00.000Z
- Updated: 2026-09-14T21:30:08.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5136718

Evoke Pharma says it is preparing a 505(b)(2) NDA for Gimoti (metoclopramide), indicated for relieving symptoms associated with acute and recurrent diabetic gastroparesis in adult women. The product is based on the company’s patented nasal delivery formulation technology.

Evoke says it recently met with FDA under a pre-NDA meeting request to discuss the content of the regulatory, chemistry, manufacturing, and control (CMC), and non-clinical sections. “Based on the FDA’s response to the information package and the pre-NDA meeting discussion, Evoke believes it now has the information needed to complete these sections of the NDA in a manner that will be acceptable for the FDA’s review of the complete package,” the company says. Additionally, it was agreed that Evoke will request to meet with the agency in the near future to discuss the clinical data that will comprise the remaining sections of the NDA.