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

By Dr. Matthew Watson

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.

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

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