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DuPont Merck, Barr NOV letters mark ad division effort to referee generic substitution dispute.

Executive Summary

DUPONT MERCK DISCUSSION OF AVERAGE BIOEQUIVALENCE "SHORTCOMINGS" ARE APPROPRIATE, the company maintained after receiving an Aug. 26 notice of violation letter from FDA's Division of Drug Marketing, Advertising & Communications. The letter charged that DuPont Merck "made misleading statements about bioequivalence" of generic warfarin in Coumadin slide presentations, DDMAC Deputy Director Norman Drezin reported at a Food & Drug Law Institute meeting Sept. 3 in Washington, D.C.



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