RVL Pharmaceuticals plc

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Products, Regulatory

Osmotica Pharmaceuticals PLC Receives Complete Response Letter From U.S. Food And Drug Administration For Arbaclofen Extended Release Tablets

Published: 12/29/2020 22:34 GMT
(OSMT) - Osmotica Pharmaceuticals Plc Receives Complete Response Letter From U.S. Food and Drug Administration for Arbaclofen Extended Release Tablets.
Osmotica Pharmaceuticals - Crl Stated Co Did Not Provide Adequate Justification for Statistical Analysis, in a Co-primary Endpoint for Arbaclofen.
Osmotica Pharmaceuticals Plc - FDA Recommendred That Co Conduct a New Study in Order to Provide Substantial Evidence of Efficacy of Arbaclofen.
Osmotica Pharmaceuticals Plc - Intends to Review Crl With Its Advisors and to Request a Meeting With FDA to Discuss Their Recommendations.
Osmotica Pharmaceuticals - "we Believe We Have Provided Data Supporting Efficacy and Safety for Both 40 Mg/day and 80 Mg/day Doses of Arbaclofen".