Metozolv ODT Approval History

  • FDA approved: Yes (First approved September 4th, 2009)
  • Brand name: Metozolv ODT
  • Generic name: metoclopramide
  • Company: Salix Pharmaceuticals, Ltd.
  • Treatment for: GERD, Gastroparesis

Metozolv ODT is a fast–dissolving formulation of metoclopramide for the short–term treatment of adults with gastroesophageal reflux and for the relief of symptoms associated with diabetic gastroparesis.

FDA Approval History for Metozolv ODT

DateArticle
Sep  8, 2009Approval Salix Receives FDA Marketing Approval for Metozolv ODT (Orally Disintegrating Tablets) for Relief of Diabetic Gastroparesis and Symptomatic Documented GERD
Feb 27, 2009Salix Announces FDA Complete Response Letter for Metozolv ODT
Nov 18, 2008FDA Extends Metozolv ODT Review Date

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web3)