FDA approves Adzenys XR-ODT (amphetamine extended release oral) for ADHD- Neos Therapeutics
The FDA has approved Adzenys XR-ODT (amphetamine extended release oral), from Neos Therapeutics, for the treatment of ADHD in patients six years and older. With this approval, Adzenys XR-ODT is the first and only extended-release orally disintegrating tablet (ODT) for the treatment of ADHD.
Adzenys XR-ODT was approved by the FDA via the 505(b) regulatory pathway. The clinical program demonstrated that Adzenys XR-ODT is bioequivalent to a previously approved mixed amphetamine salts extended-release capsule (Adderall XR1), one of the most commonly prescribed medications for the treatment of ADHD. Adzenys XR-ODT will be available in six dosage strengths, equivalent to the Adderall XR1 dosage strengths, thus allowing healthcare providers to individualize the dose.
Comment: Adzenys XR-ODT contains amphetamine loaded onto a mixture of immediate release and polymer-coated, delayed-release resin particles. Adzenys XR-ODT is patent-protected and is not a generic of amphetamine mixed salts XR capsules.
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.
1 mins