ARTICLE | Clinical News

NT-0102 regulatory update

November 23, 2015 8:00 AM UTC

FDA issued a complete response letter to Neos for Cotempla XR-ODT to treat ADHD. In the letter, Neos said FDA requested the company conduct a bridging study to demonstrate bioequivalence between clinical trial material and the product to be marketed, including an assessment of food effect, and provide validation and 3 months of stability data. Neos said the agency did not raise safety issues. ...