NT 0202 (extended release (ODT) amphetamine polistirex) refiled with FDA for ADHD-Neos Therapeutics
Neos Therapeutics has resubmitted a New Drug Application to the FDA for its amphetamine XR orally disintegrating tablet product candidate, NT 0202 (extended release (ODT) amphetamine polistirex), for the treatment of ADHD. The NT 0202 NDA resubmission provides information to specifically address the FDA-issued Complete Response Letter received in September 2013.
This includes the results from an additional pharmacokinetic study which was conducted with NT 0202 that utilised a commercial-scale manufacturing process, and the requisite stability data. This submission is a Class 2 resubmission, with a target six-month PDUFA review period. If approved, NT 0202 will be the first amphetamine XR-ODT for ADHD.
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