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Neos' ADHD Drug Won't Launch Until 2017 As FDA Requires Clinical-Commercial Bridging Study

 
• By Brenda Sandburg

Complete response letter seeks assessment of food effect of Cotempla XR-ODT (methylphenidate extended-release orally disintegrating tablets).

Neos Therapeutics Inc.’s first branded product launch will be delayed as FDA seeks further data to assure that the attention deficit/hyperactivity disorder drug Cotempla XR-ODT (methylphenidate extended-release orally disintegrating tablets) used in clinical trials is bioequivalent to the commercial product.

The company announced Nov. 10 that it had received a complete response letter from the agency that prevents approval of the NDA in its current form

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