FDA sets action date for Osmotica’s Arbaclofen in MS

The FDA has set a December 29 action date for its review of Osmotica Pharmaceutics’ (OSMT +1.2%) refiled marketing application seeking approval of arbaclofen extended-release tablets for the treatment of spasticity in multiple sclerosis patients.

The amended submission includes data from two studies, a Phase 3 and its long-term open-label extension.

https://seekingalpha.com/news/3592653-fda-sets-action-date-for-osmoticas-arbaclofen