REGULATORY UPDATE: FDA Announces Resolution of WinRho RhIG Shortage

The U.S. Food and Drug Administration (FDA) reported that the shortage of WinRho Rho(D) immune globulin (RhIG), manufactured by Kamada Ltd, has now been resolved. However, the shortage of RhoGAM (RhIG), manufactured by Kedrion Biopharma Inc., is ongoing.

The shortage, first announced in December 2023, was caused by issues in the anti-D plasma market and manufacturing deviations. Initially affecting only one U.S. manufacturer, the shortage soon expanded to include other RhIG manufacturers.

To assist the blood community during the time of shortage, earlier this year AABB released Association Bulletin (AB) #24-02, which provides information and resources to inform clinical practice decisions and inventory management strategies in the event of RhIG shortages.

Individuals with additional questions are invited to contact regulatory@aabb.org.