Neos Therapeutics Receives CRL from FDA for Cotempla XR-ODT

Neos Therapeutics, Inc.

today announced that the Company received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the Company's New Drug Application (NDA) for Cotempla XR-ODT™ (Methylphenidate Extended Release Orally Disintegrating) 10mg, 20mg, and 30mg tablets. Neos Therapeutics also announced financial results for the third quarter ended September 30, 2015. Complete Response Letter from the FDA for Cotempla XR-ODT As the Company previously disclosed, the Company was informed on October 16, 2015 that the FDA had identified unspecified deficiencies that preclude discussion of labeling and postmarketing requirements/commitments, and had set November 9, 2015 as the Prescription Drug User Fee Act (PDUFA) goal date for a decision on the NDA. A CRL is issued by the FDA's Center for Drug Evaluation and Research when it has completed its review of an NDA and questions remain that preclude the approval of the NDA