FDA to Consider Regadenoson

 

December 5, 2006

CV Therapeutics has announced it will file a new drug application to the FDA for its regadenoson agent in mid-2007 following positive results from a late-stage trial, the Associated Press reported Monday.

Regadenoson is used in myocardial perfusion imaging studies, or studies on coronary artery disease. CV Therapeutics said in late-stage trials regadenoson was comparable to Adenoscan, another drug used in MPI studies.

If regadenoson is approved by the FDA, Astellas Pharma US Inc. will control its commercial sale in the U.S., and CV Therapeutics will hold retail rights to the drug outside of North America.

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