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Wyeth Announces FDA Approval for BeneFIX® Product Enhancements
 

Wyeth Pharmaceuticals recently announced that it has received U.S. Food and Drug
Administration approval for product enhancements to BeneFIX®, its recombinant factor
IX product.

According to a press release issued by Wyeth, one of these enhancements allows patients
to use a lower volume of diluent, the liquid used to dilute factor before it is administered.
The change affects hemophilia B patients currently using the most common dosage
strength of 1,000 international units (IU) and would lower the overall volume of
BeneFIX® infused. Other approved enhancements include a needleless reconstitution kit,
new pre-filled syringes and a vial size of 2,000 IUs.

“Each of these product enhancements is a first for the treatment of hemophilia B,”
said Gary L. Stiles, MD, executive vice president and chief medical officer at Wyeth
Pharmaceuticals. “These new features were designed to enable BeneFIX® patients to
spend less time preparing their factor product, to prepare it more safely and to have
additional time for themselves.”

BeneFIX® is used to control and prevent hemorrhagic episodes in patients with
hemophilia B, including bleeding related to surgery.

Source: Wyeth press release dated March 26, 2007