The FDA has issued a nonapprovable letter to Japan's Astellas Pharma for a new formulation of its drug Prograf for heart transplant patients. But the agency also said that the drug was approvable for liver and kidney patients while asking for additional information before a final decision is made. That delay sent shares of Astellas down more than five percent, although company officials said they had not given up hope of an approval. The patent on Prograf, which earned $1.4 billion last year, expires in 2008. One analyst noted that if Astellas ended up with an approval for kidney and liver patients the company would be able to protect its market share.
- here's the release on Prograf from Astellas
ALSO: Kirin Brewery and Astellas have inked a deal to collaborate on the development of an anti-CD40 antagonistic monoclonal antibody. Release (.pdf)
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