Hoechst Marion Roussel Anzemet launch awaits FDA labeling negotiations; dolasetron approved Sept. 11.
Executive Summary
HMR ANZEMET LAUNCH AWAITS FDA LABELING NEGOTIATIONS with Hoechst Marion Roussel following the Sept. 11 approval of the anti-emetic agent. Anzemet (dolasetron) 50 and 100 mg tablets were approved for prevention of chemotherapy-induced nausea and vomiting and prevention of postoperative nausea and vomiting. Anzemet 20 mg/mL I.V. gained an additional approval for the treatment of postoperative nausea and vomiting. Advertising for Anzemet will be handled by NCI in New York.