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federal-court

Pacira sues FDA over pain drug marketing restrictions

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.

Environmental, public health groups sue FDA over feed additive

By P.J. Huffstutter CHICAGO (Reuters) – A group of environmental and public health groups sued the U.S. Food and Drug Administration on Thursday, seeking to set aside the agency’s approvals for feed additives containing ractopamine that are used to boost the weight of cattle and pigs. The groups, in two related lawsuits filed in federal court, claim that the FDA failed to adequately assess environmental and health issues related to ractopamine. Used for more than a decade in the U.S. …