Baxter International has received the FDA's approval to market Rixubis, or coagulation factor IX (recombinant), for the treatment of children with hemophilia B. The drug was approved for use in routine prophylaxis, perioperative management and control of bleeding episodes.
Baxter International said Gammagard Liquid received additional marketing approval from the FDA to treat multifocal motor neuropathy. The drug initially was approved for a weakened immune system in 2005.
The FDA is allowing subcutaneous, or under-the-skin, administration of Gammagard Liquid, Baxter International's treatment for primary immunodeficiency. The prescription drug is also delivered by IV infusion.
The active ingredient in batches of Baxter International's recalled drug heparin contained a foreign substance similar in chemical composition to the blood thinner, the FDA said Wednesday. The agency is investigating whether the supplies, which came from China, were deliberately tainted. Baxter said that the root cause of the contamination may be tied to the Chinese suppliers or the processing of the product before it was handed to the drugmaker.