Posted from: Friday, October 30, 2015 - 11:30 AM - Present

Dyanavel XR Approved for ADHD

October 20, 2015 – The U.S. Food and Drug Administration approved Dyanavel XR (extended-release oral suspension of amphetamine), manufactured by Tris Pharmaceuticals. Dyanavel XR is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in children at least six years old and includes both immediate-release and extended-release amphetamine made possible through its proprietary process. This process allowed for effectiveness that could start within an hour and last approximately 13 hours during clinical testing. Dyanavel XR is dispensed in bottles containing 464mL (about 15.5 ounces) with 2.5mg of amphetamine per mL, as well as an oral syringe marked accurately in mL increments. Recommended dosing for children beginning treatment with Dyanavel XR is 2.5mL or 5mL each morning; and may be increased up to 20mg per day if ADHD is not managed by lower doses. Dyanavel XR is a schedule II controlled substance and includes a boxed warning that it could be subject to abuse and patients on it may develop dependency. Pricing information for Dyanavel XR is currently unavailable.  Tris Pharmaceuticals plans to launch Dyanavel XR in 2016.

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Last Updated Thursday, October 17, 2019 - 08:31 AM.