FDA to Review NT0202 as Possible ADHD Treatment
Neos Therapeutics announced that the FDA has accepted for review its New Drug Application (NDA) filing for NT0202, an extended-release (XR) orally disintegrating tablet (ODT) formulation of amphetamine polistirex for the treatment of attention deficit hyperactivity disorder (ADHD).
NT020 is manufactured using Neos' proprietary extended-release technology. The company is seeking approval to manufacture and market the product in the U.S.
Approval of NT0202 will provide an alternative formulation from currently available ADHD formulations. NT020 will be the first once daily, extended-release orally disintegrating tablet available for patients with ADHD if approved. It will provide a convenient, easy to use dosage form that can be taken without water and is an option for patients of all ages who have difficulty, or do not like to swallow pills.
For more information call (847) 597-1980 or visit www.neostx.com.