Barr suspends warfarin educational campaign following DuPont Merck complaint about off-label info.
Executive Summary
BARR WARFARIN EDUCATIONAL MATERIAL SHIPMENT STOPPED PENDING REVIEW of complaints made to FDA by DuPont Merck, which manufactures branded warfarin as Coumadin. DuPont Merck filed a complaint with FDA's Division of Drug Marketing, Advertising & Communications on Aug. 1, claiming that Barr's materials, prepared to support the launch of generic warfarin, contain "information about unapproved indications and false and misleading statements." Barr launched the generic July 28 ("The Pink Sheet" Aug. 4, In Brief). DuPont Merck has been working to limit acceptance of generic warfarin by supporting laws restricting switches of narrow therapeutic index drugs in several states ("The Pink Sheet" June 2, T&G-6).
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