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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Review Letter - XYNTHA

Our STN: BL: 125264/0

Wyeth Pharmaceuticals, Inc.
Attention: Joyce Schwenk
P.O. Box 8299
Philadelphia, PA 19101-8299

Dear Ms. Schwenk:

This letter is in regard to your biologics license application (BLA) submitted under section 351 of the Public Health Service Act.

We have completed an initial review of your application dated 25-April-2007 for Antihemophilic Factor (Recombinant), Plasma/Albumin Free Method to determine its acceptability for filing. Under 21 CFR 601.2(a), we have filed your application today. The review goal date is 23-Feb-2008. This acknowledgment of filing does not mean that we have issued a license nor does it represent any evaluation of the adequacy of the data submitted.

At this time, we have not identified any potential review issues. Our filing review is only a preliminary review, and deficiencies may be identified during substantive review of your application. Following a review of the application, we shall advise you in writing of any action we have taken and request additional information if needed.

If you have any questions, please contact the Regulatory Project Manager, Pauline Cottrell at (301) 827-6162 or Franklin Stephenson at (301)827-6165.

Sincerely yours,

/Alan E. Williams, Ph.D./
Alan E. Williams, Ph.D.
Director
Division of Blood Applications
Office of Blood Research and Review
Center for Biologics Evaluation and Research