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Cipher isotretinoin "approvable"

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Cipher's CIP-isotretinoin is "approvable" May 1, with FDA requesting additional clinical data and further chemistry, manufacturing and controls details, the company says May 2. The firm believes "the data is on hand," but cautions that "we cannot rule out the possibility that a further clinical trial will be required." Cipher characterizes the approvable decision as "encouraging." FDA initially had refused to file the application (1Pharmaceutical Approvals Monthly September 2005, In Brief). Cipher claims its formulation of the retinoid has food effect advantages over Roche's Accutane and generic isotretinoins...

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