FDA Approves Room Temperature Storage of ZLB Behring's Helixate FS
FDA Approves Room Temperature Storage of ZLB Behring's Helixate FS
Extended Storage Labeling Provides Greater Flexibility for Individuals Living with Hemophilia A
KING OF PRUSSIA, Pa., October 7, 2005 - ZLB Behring announced today that Helixate FS has received approval to be stored at room temperature (up to 25(degree) C, 77(degree) F) for three months. The new storage guidelines for the treatment will provide users with greater flexibility and simplify storage options.
The United States Food and Drug Administration (FDA) approved the storage labeling change based on data from testing to assure the labeled potency (number of recombinant FVIII units contained in a vial) remains within specified limits through the expiration date of the product. The room temperature storage option is expected to be a significant convenience for Helixate FS users.
"This is great news to moms like me," said Rhonda Boni-Burden, mother of a child with hemophilia A. "This will allow greater flexibility when traveling and while attending sporting events. This really is a welcome convenience."
Starting in November 2005, each package of Helixate FS will include a special notification with details on the new labeling. While the new room temperature storage option may be used, ZLB Behring recommends refrigerating (2(degree)- 8(degree) C, 36(degree)- 46(degree) F) Helixate FS whenever possible.
About Helixate FS
Helixate FS is a recombinant factor VIII treatment for hemophilia A that offers a more convenient administration by utilizing a 2.5 mL volume diluent, one of the smallest among available factor VIII products. Helixate FS does not use albumin in its purification or formulation and includes a solvent/detergent viral inactivation step. The most frequently reported adverse event was local injection site reactions. Known hypersensitivity to mouse or hamster protein may be a contraindication to the use of Helixate FS. For additional details, see full prescribing information.
About Hemophilia
Hemophilia is an inherited bleeding disorder characterized by prolonged or spontaneous bleeding, especially into the muscles, joints, or internal organs. About 17,000 Americans have hemophilia. The disease is caused by deficient or defective blood coagulation proteins, known as factor VIII or IX. The most common form of the disease is hemophilia A, or classic hemophilia, in which the clotting factor VIII is either deficient or defective. Hemophilia B is characterized by deficient or defective factor IX.
Source: ZLB Behring
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