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.
