Astra/Merck's Roxiam
Executive Summary
NDA withdrawn from FDA following reports of aplastic anemia associated with schizophrenia drug, Merck announces Jan. 7. Merck filed the NDA in January of 1993. In October, Merck notified U.S. clinical investigators that eight cases of the potentially fatal hematologic disorder had been reported in European patients taking remoxipride ('The Pink Sheet" Nov. 8, 1993, T&G-3). There have been two deaths associated with the use of dopamine D[2] receptor antagonist. Merck said the Swedish company AB Astra is "discussing withdrawal procedures with regulatory agencies" in the 15 European countries in which remoxipride has been marketed