Osmotica Pharmaceuticals receives PDUFA date
Osmotica Pharmaceuticals Plc (OSMT) reported that the FDA has set December 29, 2020 as the PDUFA date for arbaclofen extended release (ER) tablets. The company also stated that the regulatory body considered its resubmission to the NDA for the drug candidate a complete, class 2 response to action letter issued on July 9, 2016.
Osmotica recently resubmitted its New Drug Application for arbaclofen. The drug candidate is designed to alleviate spasticity in Multiple Sclerosis patients. The resubmission application material included positive data obtained from recently concluded 12-month open