By Brendan Pierson NEW YORK (Reuters) – Pacira Pharmaceuticals Inc on Tuesday filed a lawsuit seeking a court order allowing it to promote its post-surgery pain drug, Exparel, for a wide range of surgeries, which the U.S. Food and Drug Administration opposes.
The lawsuit, filed in federal court in Manhattan, cites another New York judge’s recent decision allowing Irish drugmaker Amarin Plc to market its fish oil drug Vascepa for unapproved, or off-label, uses, though Pacira contends that its own marketing is not for off-label use. Pacira, however, has promoted it for use in all kinds of surgeries.
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Pacira sues FDA over pain drug marketing restrictions