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A black box warning is the strongest drug warning issued by the FDA. ... (clozapine), the only drug known to be both effective and well-tolerated for treating psychosis in Parkinson's patients, ...
Feb. 20, 2002 — FDA and Novartis have strengthened the BOXED WARNING and WARNINGS sections of the prescribing information (PI) for Clozaril (clozapine) as follows: (1) The previously existing ...