CSL Behring LLC has informed the Food and Drug Administration (FDA) that they have experienced manufacturing delays for their product Zemaira 1000mg (alpha1-proteinase inhibitor [human]).
Zemaira is indicated for chronic augmentation and maintenance therapy in adults with alpha1-proteinase inhibitor deficiency and clinical evidence of emphysema. The product is supplied in a single-use vial containing approximately 1000mg, 4000mg, or 5000mg of functionally active alpha1-proteinase inhibitor as a lyophilized powder for reconstitution.
The manufacturing delays have impacted supply plans and created supply disruptions. Customers may experience intermittent availability of Zemaira 1000mg, NDC Number 0053-7211-01. The Company plans to continuously expedite the resupply of the affected product.
CBER-regulated products: current shortages. News release. US Food and Drug Administration. Accessed November 18, 2021. https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/cber-regulated-products-current-shortages.