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Manufacturing process to standardize lovastatin in Cholestin cited by agency.

This article was originally published in The Tan Sheet

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Executive Summary

CHOLESTIN MANUFACTURING PROCESS INVOLVING STANDARDIZED LOVASTATIN content is cited by FDA to support its conclusion that Pharmanex intends primarily to manufacture lovastatin. Evidence the company is manufacturing the drug "consists of material indicating that Pharmanex purposely designed a manufacturing process intended consistently to maximize and standardize levels of lovastatin in Cholestin," FDA maintains. The agency's arguments were made in a May 20 letter to Pharmanex.

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