NDA withdrawn from FDA following reports of aplastic anemia associated with schizophrenia drug, Merck announces Jan. 7.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 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
You may also be interested in...
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011
FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials
Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth