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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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1/16/2008 Fax 1 - 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, 22-Jan, 2008 in order to continue their review.

  • Please provide the PK data for 7 children (ages between 12 to 16 years) mentioned in your labeling (under 8.4, pediatric use). The data should consist of age, body weight, concentration vs time data, and the relevant PK parameters.

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

Thanks,

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