Neos Therapeutics, a pharmaceutical company with a late‐stage pipeline of innovative extended-release (XR) product candidates for the treatment of attention deficit hyperactivity disorder (ADHD), has announced that, on October 16, 2015, the company received a notification from the U.S. Food and Drug Administration (FDA) stating that, as part of its ongoing review of the Company’s New Drug Application (NDA) for Cotempla XR-ODT (Methylphenidate Extended Release Orally Disintegrating) 10 mg, 20mg, and 30 mg tablets, it has identified deficiencies that preclude discussion of labeling and postmarketing requirements/commitments at this time. The FDA stated that this notification does not reflect a final decision on the information under review. In a letter dated March 24, 2015, the FDA had set November 9, 2015 as the target date for a decision on the NDA.
“Although the FDA has not provided us with any information regarding the nature of the deficiencies, we intend to work closely with the FDA to understand the nature of any such deficiencies once identified to us and resolve them as quickly as possible,” said Vipin K. Garg, Ph.D., President and CEO of Neos Therapeutics. “We look forward to moving ahead with our plan to bring the benefits of Cotempla XR-ODT and our two additional product candidates to patients with ADHD as potential novel treatment options.”
Under the time frames negotiated as a result of the Prescription Drug User Fee Act (PDUFA), the FDA set a goal date of January 27, 2016 for the Company’s amphetamine XR-ODT, or NT-0202. Neos also manufactures and markets a generic equivalent to the branded product Tussionex®1