Neos Therapeutics (NEOS) Announces Submission of NT-0201 NDA to U.S. FDA
- Wall Street falls with financials, other post-election gainers
- The FTC Confirms Antitrust Charges Against Qualcomm (QCOM) for Monopolizing Semiconductor Device Used in Cell Phones
- United Airlines (UAL) Tops Q4 EPS by 5c
- Obama shortens sentence of Manning, who gave secrets to WikiLeaks
- After-Hours Stock Movers 01/17: (SHLO) Higher; (GIMO) (AFAM) (CSX) Lower (more...)
Get access to the best calls on Wall Street with StreetInsider.com's Ratings Insider Elite. Get your Free Trial here.
Neos Therapeutics, Inc. (Nasdaq: NEOS) announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its Amphetamine XR oral suspension drug candidate, NT-0201, an ADHD medication based on its proprietary modified‐release drug delivery technology platforms.
“This NDA submission for NT-0201 is another important milestone for our company, as we continue to build out our ADHD product portfolio,” said Vipin K. Garg, Ph.D., President and CEO of Neos Therapeutics. “Additionally, we expect to resubmit the NDA for Cotempla XR-ODT™, our methylphenidate extended-release orally disintegrating tablet, this quarter. By the fall of 2017, with NT-0201 and Cotempla XR-ODT, if approved, and our already marketed product, Adzenys XR-ODT, we hope to offer patient-friendly treatment options for both of the stimulant medications that are most widely prescribed for the treatment of ADHD.”
NT-0201 is the company’s second extended-release amphetamine product candidate for the treatment of ADHD. The first, an extended-release orally disintegrating tablet, Adzenys XR-ODTTM, was approved by the FDA in January and was launched in May 2016. NT-0201 is a once-daily, extended-release liquid medication that does not require refrigeration or reconstitution at the pharmacy level. If approved, NT-0201 is designed to provide an additional treatment option for patients with ADHD.
Serious News for Serious Traders! Try StreetInsider.com Premium Free!
You May Also Be Interested In
- Jazz Pharmaceuticals (JAZZ) Announces First Patient Enrolled in Phase 3 Clinical Trial Evaluating Defibrotide for Prevention of VOD
- JCPenney (JCP) Launches Nike (NKE) Shops
- Neurocrine Biosciences (NBIX) Reports Results from Phase II Clinical Study of VMAT2 Inhibitor INGREZZA
Create E-mail Alert Related CategoriesCorporate News, FDA, Management Comments
Sign up for StreetInsider Free!
Receive full access to all new and archived articles, unlimited portfolio tracking, e-mail alerts, custom newswires and RSS feeds - and more!