NorthStar Medical Radioisotopes of Beloit, a radiopharmaceutical company, announced Wednesday that the U.S. Food & Drug Administration accepted its Type II Drug Master File submission for the company’s no-carrier-added (n.c.a) Actinium-225 (Ac-225).
This allows n.c.a. Ac-225 for use in development of radiopharmaceutical medicines and allows pharmaceutical partners to use its Ac‑225 supply for alpha therapy development and cancer treatment.
“FDA acceptance of our n.c.a. Ac‑225 Drug Master File, together with our cGMP manufacturing capabilities, establishes NorthStar as a regulatory-ready and operationally proven supply partner for targeted alpha therapies,” Dr. Frank Scholz, president and CEO of NorthStar, said in a statement.
In January, NorthStar announced the successful production of commercial-scale Ac-225.
