FDA Letter On Clozapine Trials

23 January 1995

The US Food and Drug Administration has reported that it is to issue a letter by the end of this month on cardiovascular events associated with clozapine in bioequivalence trials with healthy volunteers. The drafting of the letter follows submissions by Sandoz and Zenith Labs reporting these side effects.

Zenith suspended trials of its generic formulation of clozapine after four patients suffered "serious adverse events." Zenith added that it is unlikely that other firms will accept Sandoz' claim that cardiac arrest is possible in normal patients. Clozapine, which is marketed by Sandoz under the tradename Clozaril, came off-patent in September. Bioequivalence testing in schizophrenics is likely to be more expensive than using healthy volunteers.

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