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# Shire Files NDA for Chewable Vyvanse
- URL: https://www.fdaweb.com/shire-files-nda-for-chewable-vyvanse/
- Published: 2016-04-14T12:00:00.000Z
- Updated: 2026-09-14T20:54:42.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5135374

> Shire has submitted an NDA for a chewable tablet formulation of Vyvanse (lisdexamfetamine dimesylate) for treating attention-deficit/hyperactivity disorder patients who may have difficulty swallowing or opening a capsule. The submission is based on data from two clinical pharmacology studies that demonstrated the chewable tablet formulation is bioequivalent to a capsule formulation, which was approved by the agency in 2007\. The data also “established that the chewable tablet formulation is bioequivalent in both a fasting and non-fasting state,” Shire says. “Based on these clinical pharmacology studies, the clinical profile of Vyvanse chewable tablets is thought to be comparable to the current formulation.”