SELDANE WITHDRAWAL REQUESTED BY FDA BECAUSE "UNIQUE MOLECULE" STATUS HAS ENDED, AGENCY SAYS; HOECHST DECLARES INTENT TO FIGHT WITHDRAWAL VIA HEARING PROCESS
Executive Summary
FDA has decided to seek the withdrawal of Hoechst Marion Roussel's Seldane due to the potential for cardiac side effects because it is no longer a "unique molecule," the agency explains in a Jan. 14 Federal Register notice.