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ARTICLE | Clinical News

Amphetamine XR-ODT regulatory update

September 7, 2015 7:00 AM UTC

Neos resubmitted an NDA to FDA for NT-0202 to treat ADHD. Neos expects the agency to designate the NDA as a Class 2 resubmission, with a 6-month review. The extended-release, orally disintegrating tablet formulation of amphetamine polistirex uses Neos’ Rapidly Disintegrating Ionic Masking (RDIM) technology. In 2013, FDA issued a complete response letter for the product citing CMC-related issues. Neos said its resubmission includes data from an additional pharmacokinetic study of NT-0202 that used a commercial-scale manufacturing process, as well as stability data. ...