Bolar's diltiazem

NDA for generic version of Marion Merrell Dow's Cardizem is withdrawn, the generic firm announces Aug. 6. Bolar says it has notified FDA that it is withdrawing the application for the immediate-release form of the calcium channel blocker "without prejudice." Bolar noted that "questions raised by the FDA with regard to certain portions of the application prepared by Bolar's old management; FDA policies that might require resubmission of the NDA; and the recent approvals of ANDAs for this product make it economically unfeasible to continue to pursue approval." Mylan received a tentative approval in March for diltiazem and MMD has announced a generic licensing agreement with Rugby pending expiration of MMD's ANDA exclusivity on Nov. 5, 1992. Bolar had filed the NDA in 1989 under a joint development agreement with Rorer in the hope of preempting other generic competitors.