FDA Settles over Promotion of Off-Label Use of Drug

The Food and Drug Administration has decided not to appeal a federal judge’s ruling that drug maker Amarin has a First Amendment right to promote its fish-oil pill for unapproved uses, as long as the information it provides doctors is truthful and not misleading.

The company announced Tuesday that it had settled the case with the agency, in a move that will allow Amarin to continue to communicate with physicians about off-label uses for its drug, Vascepa.

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