FDA Approves Octaplas for Treating Patients With Blood Clotting Disorders

Jan. 17, 2013, 8:46 PM UTC

The Food and Drug Administration Jan. 17 said that it approved Octaplas to treat patients with blood clotting disorders.

Octaplas, manufactured by Switzerland-based company Octapharma, is a pooled plasma (human) blood product for the replacement of clotting proteins (coagulation factors) in certain medical conditions where patients have insufficient levels, the agency said. Octaplas has been used extensively in Europe and other countries, FDA noted, adding that more than 2 million patients have been treated with more than 7 million doses of Octaplas outside of the United States.

Clotting protein deficiencies can cause excessive bleeding or excessive clotting, according to FDA, ...

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