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Macugen Approval Awaits CMC Review; Committee Supports Efficacy

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

The final decision on Pfizer/Eyetech’s Macugen awaits review of the chemistry and manufacturing sections of the NDA, FDA said during the Dermatologic & Ophthalmic Drug Products Advisory Committee’s Aug. 27 review of the clinical data.
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