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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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


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.