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Lyrica Reviewer Concerns On Vision, Skin Led To Consults With Top FDA Staff

Executive Summary

Top CDER officials moderated the primary reviewers' inclination to delay approval of Pfizer's Lyrica (pregabalin) until more data on dermatologic and visual effects better characterized the drug's risks, review documents show

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Mircera Reviewers Turned To Top-Level FDA Briefing With CRP Concerns

Unlike trials of other ESAs, Roche’s Mircera studies excluded patients with elevated levels of C-reactive protein, a marker for inflammation. In a move reflective of growing use of interdisciplinary and cross-division expertise within FDA, the review division sought center-level “regulatory briefing” to determine if CRP screening produced a database that was not characteristic of the market. The briefing found the rate of exclusion due to CRP screening insufficient to delay approval of Mircera

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