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# Neos Therapeutics Files NDA for ADHD Drug
- URL: https://www.fdaweb.com/neos-therapeutics-files-nda-for-adhd-drug/
- Published: 2016-11-17T12:00:00.000Z
- Updated: 2026-09-14T21:48:47.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5137372

Neos Therapeutics has submitted an NDA for its Amphetamine XR oral suspension drug candidate, NT-0201, an attention-deficit hyperactivity disorder medication based on the company’s proprietary modified‐release drug delivery technology platforms.  

Neos says it is also planning to resubmit by year end its NDA for Cotempla XR-ODT (methylphenidate extended release orally disintegrating) tablets for treating attention deficit hyperactivity disorder. In 2015, FDA issued a complete response letter ([see story](http://fdaweb.com/login.php?sa=v&aid=D5133919&searchWords=neos&cate=S&stid=%241%24gY..pz5.%24uqZ4OObs7MX615J7bod%2FK0&ref=fdaweb.com)) that identified “unspecified deficiencies that preclude discussion of labeling and postmarketing requirements/commitments,” it says. The letter required the company to conduct a bridging study to demonstrate bioequivalence between the clinical trial material and to-be-marketed drug product, including an assessment of food effect, Neos says. Additionally, the agency asked for validation and three months of stability data. “The FDA did not raise any safety or efficacy issues with the clinical data previously provided beyond the need for an adequate bridge between the clinical trial material and the to-be-marketed drug product,” it says.