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FDA Approves Change In Storage Conditions For Humate-P

Armen Hareyan's picture


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FDA approved a change in the storage conditions for Humate-P, a treatment for bleeding in certain patients with hemophilia A or von Willebrand Disease (vWD).

The treatment, a protein that helps blood form the clots necessary to stop bleeding, can now be safely stored for up to two years at 77 degrees Fahrenheit. Previously, Humate-P required colder, refrigerator-level temperatures for that storage length.

Approval of this change was based on stability data submitted by the company including laboratory tests of product potency conducted under different temperatures.