Astellas faces new delay for Advagraf approval

Japan's Astellas Pharma has run into a new roadblock in its pursuit of regulatory approval of Advagraf, its second generation version of the blockbuster transplant drug Prograf. The FDA has raised questions about the safety and efficacy of the drug for use in liver transplants. Last March the FDA issued an action letter [1] regarding Advagraf for kidney transplants. The agency's action letters typically mean at least a six month delay before regulators will approve it.

Advagraf is already approved in Europe. Prograf earned $2 billion in sales last year.

- read the story [2] in Yahoo News

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