Otsuka Pletal Needs Further Enzyme Inhibition Studies, Advisory Cmte. Says
The effect of P450 liver enzyme inhibitors on Otsuka's Pletal metabolism requires further study, FDA's Cardiovascular & Renal Drugs Advisory Committee indicated during a July 9 review of the drug for treatment of intermittent claudication. The committee agreed that FDA should approve Pletal for the indication, provided Otsuka collects additional data to better define the drug's potential mortality risk ("The Pink Sheet" July 13, p. 3).
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