Osmotica Pharmaceuticals Plc

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Osmotica Pharmaceuticals Submits Amendment To Its NDA For Arbaclofen Er Tablets To U.S. FDA

Published: 12/21/2020 23:37 GMT
Osmotica Pharmaceuticals Plc (OSMT) - Osmotica Pharmaceuticals- on December 18, Submitted an Amendment to Its NDA for Arbaclofen Er Tablets to U.S. FDA.
Osmotica Pharmaceuticals- Intends to Continue Its Discussions With the FDA to Resolve the Issues Raised in Its December 4, 2020 Letter.
Osmotica Pharma- at This Time, It is Likely That FDA Will Continue to Review NDA Past User Goal Date of December 29 for Arbaclofen Er Tablets.