FDA approves room temperature storage of ZLB Behring's Helixate FSŪ
Extended storage labeling provides greater flexibility for individuals living with hemophilia A
King of Prussia, PA--(BUSINESS WIRE)--Oct. 7, 2005 -- ZLB Behring announced today that Helixate FS has received approval to be stored at room temperature (up to 25 degrees C, 77 degrees 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 degrees- 8 degrees C, 36 degrees- 46 degrees F) Helixate FS whenever possible. Please refer to the full prescribing information for Helixate FS for complete product information. If you have additional questions, please contact ZLB Behring Medical Information at 1-800-504-5434 or visit www.zlbbehring.com.
Source: Eurekalert & others
Published on PsychCentral.com. All rights reserved.