Bayer HealthCare, Berkeley, CA, Jan. 23 (CBER).CBER's Office of Compliance and Biologics Quality (OCBQ OCBQ Office of Compliance and Biologics Quality (US FDA) ) reviewed a number of promotional pieces for Bayer's Kogenate FS [Antihemophilic Factor an·ti·he·mo·phil·ic factor n. Abbr. AHF See factor VIII. antihemophilic factor (AHF, factor VIII) Alphanate, Hemofil M, Koate-DVI, Kogenate FS, Monarc-M, Monoclate-P, Recombinate, ReFacto (Recombinant) Formulated with Sucrose] submitted as marketing product forms, including the "Free Trial Program Key Message & Q & A," "Free Trial Program Letter for Kogenate Users," "Free Trial Program Letter for Customers," and "Free Trial Program Letter for Healthcare Professionals." The agency found the promotional materials to be misleading because they failed to reveal material facts regarding the risks associated with the use of Kogenate FS. According to the FDA-approved PI, Kogenate FS is a dried concentrate preparation of antihemophilic factor produced by baby hamster hamster, Old World rodent, related to the voles, lemmings, and New World mice. There are many hamster species, classified in several genera. All are solitary, burrowing, nocturnal animals, with chunky bodies, short tails, soft, thick fur, and large external cheek kidney cells into which the human factor VIII factor VIII n. A factor in the clotting of blood, a deficiency of which is associated with hemophilia A. Also called antihemophilic factor, antihemophilic globulin, antihemophilic globulin A, gene has been introduced. The manufacturing of Kogenate FS incorporates a revised purification and formulation with sucrose that eliminates the addition of albumin (human). Kogenate FS is indicated for the treatment of classical hemophilia (hemophilia A hemophilia A n. Hemophilia due to deficiency of factor VIII, characterized by prolonged clotting time, decreased formation of thromboplastin, and diminished conversion of prothrombin. ) in which there is a demonstrated deficiency of activity of the plasma-clotting factor FVIII. The PI also includes detailed risk information including contraindications and AEs, such as, hypersensitivity-at-injection-site reactions, dizziness and rash. According the OCBQ letter, however, the "Free Trial Program" document and the various letters provided indications for use and patient population information but failed to provide any risk information. AE, F-B F-B Forward - Backward (radar image analysis) ; Doc. 13744W |
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