FDA
approval
· 2015-11-27
FDA Approved: OMEGA-3-ACID ETHYL ESTERS — Original Application (Amneal Pharmaceuticals LLC)
Summary
FDA approves Amneal's original ANDA for Omega-3-acid ethyl esters (ANDA 204940). This provides a new generic option for the treatment of hypertriglyceridemia.
Upgrade for the full analysis, importance score, and drug timeline.
Diseases / indications
Drugs mentioned
Snippet
ORIG AP for OMEGA-3-ACID ETHYL ESTERS (OMEGA-3-ACID ETHYL ESTERS)