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news.The US Food and Drug Administration (FDA) has accepted Neos Therapeutics' new drug application (NDA) 505(b)(2) filing for NT0202, an extended release (XR) orally disintegrating tablet (ODT) formulation of Amphetamine Polistirex.
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The company has developed NT0202, leveraging its extended-release technology, as a treatment to attention deficit hyperactivity disorder (ADHD) and is requesting for manufacturing and marketing approval of the product in the US.
NT0202, which can be taken without water, will be an alternative to existing ADHD formulations, according to the company.
Upon approval, NT0202 would be the first once-daily, XR ODT available for patients with ADHD.
Neos Therapeutics’ research and development (R&D) and manufacturing facilities are located in the Dallas/Fort Worth area.