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
See full press release
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