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Kapidex Approval History

  • FDA approved: Yes (First approved January 30th, 2009)
  • Brand name: Kapidex
  • Generic name: dexlansoprazole
  • Dosage form: Delayed Release Capsules
  • 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).

Development History and FDA Approval Process for Kapidex

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

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