Breaking News From Pharma & Bio Ingredients
Bayer Product Gets OK from FDA
Posted on 2005-11-28 15:12:00
Pharmaceutical and medical products firm Bayer AG said Monday that the Food and Drug Administration approved its Kogenate FS hemophilia treatment to be administered with a device known as Bio-Set.
The company said the device, which is already sold in Canada and parts of Europe, eliminates the risk of accidental needle-stick injuries during reconstitution of the blood-clotting factor that hemophiliacs take. The treatment was approved for patients with hemophilia A, the most common form of the disease, in which a blood coagulation protein known as factor VIII is either deficient or defective.
Bio-Set is a trademark and Biodome SAS, and will be launched in the United States early next year for the U.S. hemophilia community, Bayer said.
Subscribe via RSS
