Dexilant 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 History and FDA Approval Process for Dexilant
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