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Vaccines, Blood & Biologics
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
Abdu Alayash, Basil Golding and Susan Abbondanzo
Franklin Stephenson and Pauline Cottrell
125264/0 BLA (New improved manufacturing process for the drug substance)
Recommendation: BLA STN # 125264 is may be filed from a Pharmacology and Toxicology perspective.