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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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1/16/2008 Fax 2 - XYNTHA

FACSIMILE TRANSMISSION RECORD

Division of Blood Applications
1401 Rockville Pike, Suite 400N, HFM-380
Rockville, Maryland 20852-1448

FAX (301) 827-2857
TEL (301) 827-3524

FAX No. (484) 865-6462
To:   Joyce Schwenk, Wyeth Pharmaceuticals
Information Request for STN:   125264/0
Date:   January 16, 2008

The review committee for this STN request responses to the following questions in the form of an amendment to the file by COB, 25-Jan, 2008 in order to continue their review.

  • Please provide updated stability data for all the moroctocog alfa, AF-CC lots enrolled in the stability program. In addition to providing the updated stability reports, please indicate in the summary if there are any out-of-specification results for lots stored under the recommended storage conditions of ------.

If you need clarification please call me at 301-827-6162

Thanks,

Pauline Cottrell
Regulatory Project Manager
FDA/CBER/DBA/OBRR/RPMB