Neos Therapeutics Resubmits NDA for FDA Review of Amphetamine Extended-Release Orally Disintegrating Tablets to Treat ADHD

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Neos Therapeutics, Inc. (NASDAQ: NEOS today announced that it has resubmitted a New Drug Application ("NDA") to the U.S. Food and Drug Administration ("FDA") for its amphetamine XR orally disintegrating tablet ("XR-ODT") product candidate, NT‐0202, 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 utilized a commercial-scale manufacturing process, and the requisite stability data. This submission
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