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Vaccines, Blood & Biologics

Pharmacology/Toxicology Review Memorandum (6/5/2007) - XYNTHA

MEMORANDUM

Department of Health and Human Services
Food and Drug Administration
Center for Biologics Evaluation and Research

Pharmacology / Toxicology Review Memorandum

Date:
6-5-2007
From:
Paul W. Buehler
Through:
Abdu Alayash, Basil Golding and Susan Abbondanzo
To:
Franklin Stephenson and Pauline Cottrell
Subject:
125264/0 BLA (New improved manufacturing process for the drug substance)
Sponsor:
Wyeth Pharmaceuticals

Recommendation:   BLA STN # 125264 is may be filed from a Pharmacology and Toxicology perspective.

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