Barr anticipates generic warfarin approval by early second quarter, firm says.

Executive Summary

BARR IS EXPECTING GENERIC WARFARIN APPROVAL IN FIRST QUARTER "or shortly thereafter," Barr CEO Bruce Downey told an American Stock Exchange Health Care Conference in New York City Jan. 23. To produce a generic, Downey said, Barr has had to overcome "the unavailability of raw material" and "a fierce campaign among pharmacists implying that the generic substitute for the product might not be safe and effective." Barr maintains that its warfarin "is both safe and effective and deserves immediate approval." Barr must also overcome a citizen's petition filed with FDA by Coumadin (warfarin) manufacturer DuPont Merck requesting more stringent bioequivalence standards for generic versions of the anticoagulant drug ("The Pink Sheet" Oct. 14, 1996, T&G-16).