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FDA frees Biopure inventory
Cambridge, Mass.-Biopure Corp. started shipping Oxyglobin to U.S. veterinary hospitals in mid February following a nod from the U.S. Food and Drug Administration (FDA) to do so.
FDA and the company resolved its previously reported "manufacturingdocumentation issue" and the company since lifted its voluntary holdon Oxyglobin inventory. Biopure has produced and inventoried more than 20,000units of Oxyglobin since its recently expanded manufacturing facilitiesreopened, which it will use to fill more than 11,000 units on backorderbeginning in mid February, and it is continuing to manufacture new productlots for sale.
"We're grateful for our valued customers' patience and support,and we're committed to providing an uninterrupted supply of product nowthat shipments are resuming," says Rick Merrill, Biopure's directorof veterinary sales. Backorders will be filled as quickly as possible inthe order they were received, the company adds. Veterinary customers shoulddirect any shipment-related questions to Oxyglobin customer service at (888)337-0929 or rbettger@biopure.com.
"We're delighted to have this issue resolved and be back in businesswith Oxyglobin," says Biopure President and CEO Thomas A. Moore.
Oxyglobin, an oxygen therapeutic approved by FDA and the European Commission,is indicated for the treatment of anemia in dogs by increasing systemicoxygen content and improving the clinical signs associated with anemia.
The product has been widely used both as an alternative to red bloodcell transfusion (e.g., massive blood loss) and in situations where immediateoxygen-carrying support may be beneficial but blood transfusion is ineffectiveor inappropriate (e.g., immune-mediated hemolytic anemia).
These usage patterns encompass a variety of critical conditions. Unlikedonated blood, Oxyglobin is compatible with all blood types, is stable atroom temperature (2º to 30ºC) for three years, and goes througha pharmaceutical manufacturing process that is validated to remove potentialcontaminants.
