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.
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.
For more information call (972) 408–1300 or visit Neostx.com.