Vaccines, Blood & Biologics
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
Regulatory Project Manager