14 April 2016 - Shire recently submitted a NDA to the U.S. FDA for a new, alternate formulation of Vyvanse (lisdexamphetamine dimesylate) as a chewable tablet for patients who may have difficulty swallowing or opening a capsule. Vyvanse capsules can be swallowed whole or consumed by opening and mixing the entire contents into water, orange juice or yoghurt. Vyvanse chewable tablets will offer an additional administration option for patients.

In the U.S., Vyvanse capsules are indicated for the treatment of Attention-Deficit/Hyperactivity Disorder in patients ages six and above and for the treatment of moderate to severe Binge Eating Disorder in adults. Vyvanse is not for weight loss. It is not known if Vyvanse is safe and effective for the treatment of obesity. The proposed indications for Vyvanse chewable tablets are the same as the currently FDA-approved indications for Vyvanse capsules.

For more details, go to: https://www.shire.com/newsroom/2016/april/shire-submits-nda-to-fda-for-new-formulation-of-vyvanse