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Advagraf still waiting for FDA approval

5/15/2008

WASHINGTON Astellas says it has received a fourth approvable letter from the Food and Drug Administration for its immunosuppressant drug Advagraf, again delaying the drug’s approval.

In December 2005, the company’s U.S. subsidiary submitted an application for Advagraf for the prevention of organ rejection in kidney, liver and heart transplants.

The FDA replied with an approvable letter for liver transplantation in January 2007 to which the company responded last July.

In addition to a second approvable letter for liver transplantation, which the company said it received April 30, the FDA sent the firm two approvable letters for kidney transplantation in January 2007 and March and a not-approvable letter for heart transplantation in January 2007.

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