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Dexilant FDA Approval History

FDA Approved: Yes (First approved January 30, 2009)
Brand name: Dexilant
Generic name: dexlansoprazole
Dosage form: Delayed Release Capsules
Previous Name: Kapidex
Company: Takeda Pharmaceutical Company Limited
Treatment for: Erosive Esophagitis, GERD

Dexilant (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).

Dexilant was originally approved as Kapidex on January 30, 2009.

On March 4, 2010, Takeda Pharmaceuticals announced that Kapidex would be marketed under the product trade name Dexilant after receiving reports of dispensing errors between Kapidex and the products Casodex® (bicalutamide) and Kadian® (morphine sulfate extended-release).

Development timeline for Dexilant

Jan 27, 2016Approval FDA Approves Takeda's Dexilant SoluTab (dexlansoprazole)
Mar  4, 2010Approval Kapidex (dexlansoprazole) Renamed Dexilant in U.S. to Avoid Name Confusion
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 forTAK-390MR in Patients with Acid-Related Disorders

Further information

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