Osmotica Pharmaceuticals plc Receives Complete Response Letter from U.S. Food and Drug Administration for Arbaclofen Extended Release Tablets

Author's Avatar
Dec 29, 2020
Article's Main Image

BRIDGEWATER, N.J., Dec. 29, 2020 (GLOBE NEWSWIRE) -- Osmotica Pharmaceuticals plc (Nasdaq: OSMT) (“Osmotica” or the “Company”) today announced that the U.S. Food and Drug Administration (“FDA”) has issued a Complete Response Letter (“CRL”) regarding the Company's New Drug Application (“NDA”) seeking approval for the investigational agent arbaclofen extended release ("ER") tablets to treat spasticity resulting from multiple sclerosis.