FDA approves Novartis plant for production of Pluvicto
April 24, 2023
Novartis announced on April 21, 2023, that they received approval by the U.S. Food and Drug Administration (FDA) to begin supplying Pluvicto for U.S. commercial use from their manufacturing facility in Millburn, NJ. Capacity should increase through the second half of the year, helping to ensure stable, reliable supply to patients. Last month, ASTRO expressed concern to the FDA that without this U.S.-based facility, Novartis was unable to meet demand, and patients were either not receiving their full treatment, or their treatment was being delayed.