FDA approves International Isotopes’ I-131 therapeutic agent

Idaho-based International Isotopes has received U.S. Food and Drug Administration approval for its radioactive therapeutic agent used to treat thyroid cancers.

The agent—Sodium iodide I-131—is administered to patients with hyperthyroidism and carcinoma of the thyroid. It is naturally absorbed by thyroid glands and can be targeted directly to tumors for easier removal of cancerous tissue.

More than 50,000 adults in the United States are diagnosed with a form of thyroid cancer each year, according to the American Cancer Society.

“We are very pleased to have gained FDA approval of this important pharmaceutical product, which is the only FDA approved generic product of its type manufactured in the United States,” President and CEO Steve T. Laflin said in a statement. “Sodium iodide I-131 will be an important addition to the Company's product offerings, and we anticipate launching commercial distribution in the very near future."

In Nov. 2018, the University of Missouri Research Reactor announced it had established the first domestic supply of I-131 in more than 30 years. It is one of the few suppliers of the radioisotope in the world.