News
FDA letters to CSL, Talecris direct changes in promotional labeling for Alpha-1 augmentation products Prolastin and Zemaira
WASHINGTON—The U.S. Food and Drug Administration’s Center for Biologics Evaluation and Research (CBER) has sent letters to CSL Behring and Talecris Biotherapeutics directing the two companies to change some promotional labeling in their products used to treat Alpha-1 Antitrypsin Deficiency (Alpha-1).
CSL manufactures Zemaira; Talecris manufactures Prolastin and Prolastin-C, all given as intravenous infusions for Alpha-1 augmentation therapy.
The letters do not raise any concerns about the safety of either product.
