CAPT... When the FDA, in 2019, approved Vascepa for treating patients for the CVD indication, the approval, at that time, was....ONLY for patients with TG's of 150 mgs/dcl or more...(plus diabetes or other risk factors for CVD).
Amarin now needs to contact the FDA about this NEW information, published after 2019, and petition for a NEW LABEL hearing, which reflects the new information, published after that time...and, for the FDA,to issue their updated approval for Vascepa for the treatment of CVD patients....which does NOT have the over 150 mgms/dcl TG criterion, previously mandated in their decision five years ago.
The Generics mandate for over 500 mgms/dcl of TG for THEIR indication can stay
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