Neos Therapeutics announced that it has resubmitted a New Drug Application (NDA) to the Food and Drug Administration (FDA) for its amphetamine XR orally disintegrating tablet (XR-ODT) product candidate, NT‐0202, for the treatment of attention-deficit/hyperactivity disorder (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 that utilized a commercial-scale manufacturing process, and the requisite stability data. If approved, NT-0202 will be the first amphetamine XR-ODT for ADHD.

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Neos’ methylphenidate XR-ODT candidate, Cotempla XR‐ODT, is currently under review by the FDA and, if approved, will be the first methylphenidate XR‐ODT available for the treatment of ADHD.

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