Kapidex Approval History

  • FDA approved: Yes (First approved January 30th, 2009)
  • Brand name: Kapidex
  • Generic name: dexlansoprazole
  • Previous name: TAK-390MR
  • Company: Takeda Pharmaceutical Company Limited
  • Treatment for: Erosive Esophagitis, GERD

Kapidex (dexlansoprazole) is a proton pump inhibitor with a novel delivery system approved for the treatment of erosive esophagitis and heartburn associated with symptomatic non-erosive gastroesophageal reflux disease (GERD).

FDA Approval History for Kapidex

DateArticle
Feb  2, 2009Approval FDA Approves Kapidex (dexlansoprazole) for the Treatment of GERD
Oct 20, 2008FDA Adds Three Months to Review of Takeda's New Drug Application for TAK-390MR
Jan  4, 2008TAP Pharmaceutical Products Inc. Files New Drug Application for TAK-390MR in Patients with Acid-Related Disorders

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
(web5)