Posted by Michael Wonder on 20 Jul 2020
Osmotica Pharmaceutical announces FDA user fee goal date of 29 December 2020 for arbaclofen extended release tablets
20 July 2020 - Osmotica Pharmaceuticals, through its subsidiary Osmotica Pharmaceutical US, announced today that the U.S. FDA considers the Company’s resubmission to its new drug application for arbaclofen extended release tablets a complete, class 2 response to the 9 July 2016, action letter; the user fee goal date is 29 December 2020.
Osmotica Pharmaceuticals plc is developing arbaclofen extended release tablets for the treatment of spasticity in patients with multiple sclerosis.
This program aims to demonstrate the clinical efficacy and safety of arbaclofen extended release tablets in patients with spasticity due to multiple sclerosis.
