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RSS FeedsOsmotica Pharmaceuticals US LLC Submits Amended NDA for Arbaclofen Extended Release Tablets to U.S. Food and Drug Administration
(WorldNews Argentina)

 
 

30 june 2020 14:49:45

 
Osmotica Pharmaceuticals US LLC Submits Amended NDA for Arbaclofen Extended Release Tablets to U.S. Food and Drug Administration
(WorldNews Argentina)
 


-- 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...


 
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