Osmotica Pharmaceuticals US LLC Submits Amended NDA for Arbaclofen Extended Release Tablets to U.S. Food and Drug Administration
Osmotica Pharmaceuticals plc - Ordinary Shares (OSMT)
Last osmotica pharmaceuticals plc - ordinary shares earnings: 3/18 04:05 pm
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Source: GlobeNewswire
-- Submission based on world’s largest database of patients treated for spasticity associated with Multiple Sclerosis -- -- Demonstrated efficacy, tolerability and one-year safety results on 80 mg/day -- BRIDGEWATER, N.J., June 30, 2020 (GLOBE NEWSWIRE) -- Osmotica Pharmaceuticals plc (Nasdaq: OSMT) through its subsidiary Osmotica Pharmaceutical US LLC (“Osmotica” or the “Company”), a fully integrated biopharmaceutical company, announced today that the Company has resubmitted its New Drug Application (“NDA”) for arbaclofen extended release (“ER”) tablets for the alleviation of spasticity in Multiple Sclerosis (“MS”) patients to the U.S. Food and Drug Administration (“FDA”). “We are excited to have resubmitted our NDA for arbaclofen ER, our novel treatment, using the Osmodex technology, for MS spasticity. With the recent completion of our 12-month open-label study – assessing the long-term safety and tolerability of arbaclofen ER 80 mg/day - this resubmission also includes the ful
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