BioCentury | Jul 13, 2017
Clinical News

FDA approves Neos' Cotempla XR-ODT for ADHD

...Last month, FDA approved an NDA from Neos Therapeutics Inc. (NASDAQ:NEOS) for Cotempla XR-ODT (methylphenidate XR-ODT) to treat...
...to launch the drug this fall. In 2015, FDA issued a complete response letter for Cotempla XR-ODT...
...Neos Therapeutics Inc. (NASDAQ:NEOS), Grand Prairie, Texas Product: Cotempla XR-ODT (methylphenidate XR-ODT) (formerly NT-0102) Business: Neurology Alex Himes Cotempla XR-ODT Methylphenidate XR-ODT Neos...
BioCentury | Aug 22, 2016
Clinical News

Methylphenidate XR-ODT: Phase I data

...Neos said a 3-way crossover Phase I bridging trial showed that a single dose of Cotempla XR-ODT...
...formulation of Cotempla XR-ODT under fasted conditions. Last year, FDA issued a complete response letter for Cotempla XR-ODT...
...23, 2015). Neos Therapeutics Inc. (NASDAQ:NEOS), Grand Prairie, Texas Product: Methylphenidate XR-ODT ( Cotempla XR-ODT ) (formerly NT-0102...
BioCentury | Nov 23, 2015
Clinical News

NT-0102 regulatory update

...FDA issued a complete response letter to Neos for Cotempla XR-ODT to treat ADHD. In the letter...
...Disintegrating Ionic Masking (RDIM) technology. Neos Therapeutics Inc. (NASDAQ:NEOS), Grand Prairie, Texas Product: NT-0102 ( Cotempla XR-ODT...
BioCentury | Oct 26, 2015
Clinical News

NT-0102 regulatory update

...FDA notified Neos that the agency identified “deficiencies” in an NDA for Cotempla XR-ODT to treat ADHD...
...Disintegrating Ionic Masking (RDIM) technology. Neos Therapeutics Inc. (NASDAQ:NEOS), Grand Prairie, Texas Product: NT-0102 ( Cotempla XR-ODT...
BioCentury | Aug 24, 2015
Analyst Picks & Changes

Analyst picks & changes

...benefit and can carve out an important niche in the $10 billion-plus ADHD market." Neos' NT-0102...
...extended-release oral disintegrating tablet formulation of methylphenidate, has a Nov. 9 PDUFA date. Maris expects NT-0102...
BioCentury | Jul 24, 2015
Financial News

ADHD company Neos up after $72M IPO

...have raised $60 million and valued the company at $205.3 million. FDA is reviewing Neos' NT-0102...
BioCentury | Feb 9, 2015
Clinical News

NT-0102 regulatory update

...Neos submitted an NDA to FDA for NT-0102 to treat ADHD. The extended-release oral disintegrating tablet...
...Neos’ Rapidly Disintegrating Ionic Masking (RDIM) technology. Neos Therapeutics Inc. , Grand Prairie, Texas Product: NT-0102...
BioCentury | Jul 21, 2014
Clinical News

NT-0102: Phase III data

...U.S. Phase III trial in 87 children ages 6-12 years with ADHD showed that once-daily NT-0102...
...the primary endpoint of improving SKAMP scores from baseline to 12 hours post-dose vs. placebo. NT-0102...
...to submit an NDA to FDA for NT-0102 to treat ADHD. The company is developing NT-0102...
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