Biopure's marketing application for Hemopure accepted for U.K. review

By Elaine Rigoli

Tampa, Fla., Sept. 12 - Biopure Corp. said the United Kingdom's Medicines and Healthcare products Regulatory Agency has validated the marketing authorization application submitted July 10 for Hemopure [hemoglobin glutamer - 250 (bovine)] for the treatment of acutely anemic adult orthopedic surgery patients under 80 years of age.

The Cambridge, Mass.-based pharmaceutical company said this validation signifies that the application is complete, noting that the time period for the agency's decision may take a year or more following validation.

If marketing authorization is granted, the company would have the option to seek registration of the product in other member states in the European economic area through the mutual recognition procedure.

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