Searle

Executive Summary

Met with FDA on Aug. 26 to discuss differences between its Calan SR sustained-release verapamil product and Ivax' recently-approved generic version. At the meeting, FDA reaffirmed its position that the Ivax verapamil product is bioequivalent to Searle's Calan SR and will receive an "AB" rating. Searle petitioned the agency on Aug. 5 to stay the granting of an "AB" therapeutic equivalence rating for the Ivax product on the grounds that Ivax had not conducted "necessary" stereochemistry and chiral studies ("The Pink Sheet" Aug. 10, p. 6). The company and FDA have agreed that the issue should be reviewed by FDA's Generic Drugs Advisory Committee; however, the next meeting has not yet been scheduled.