Gimoti (Metoclopramide Nasal Spray) & Tardive Dyskinesia and Adverse Central Nervous System Reactions

Details

Basic Details

Status

Ongoing

Last Updated

Friday, March 8, 2024

Original Posting Date

Friday, July 10, 2020

Health Outcome(s)

adverse central nervous system reactions

tardive dyskinesia

Purpose

Drug and Outcome Analysis

Meets requirements of FD&C Act Sec 505(o) prior to requiring a PMR

Yes

Result(s) (3)

Characterization of Gimoti (Metoclopramide Nasal Spray) Dispensing Patterns: A Descriptive Analysis Characterization of Gimoti (Metoclopramide Nasal Spray) Dispensing Patterns: A Second Descriptive Analysis Characterization of Gimoti (Metoclopramide Nasal Spray) Dispensing Patterns: A Third Descriptive Analysis

Regulatory Link(s) (1)

FDA Approval Package Materials