Neos Therapeutics (NEOS) Posts Wider-than-Expected Q3 Loss
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Neos Therapeutics (NEOS) Receives FDA Complete Response Letter for Cotempla XR-ODT NDA
November 11, 2015 7:49 AM ESTNeos Therapeutics (Nasdaq: NEOS) 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... More
