Product Approval Information

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.