|Over a quarter ago|
International Isotopes reports FDA approval of Sodium Iodide 1-131 ANDA » 10:0602/1002/10/20
International Isotopes announced that it has received approval from the U.S. Food and Drug Administration for its SODIUM IODIDE I-131 pharmaceutical product. SODIUM IODIDE I-131 is a radioactive therapeutic agent indicated for the treatment of hyperthyroidism and carcinoma of the thyroid. The American Cancer Society estimates more than fifty thousand adults in the United States are diagnosed with thyroid cancer each year. Steve T. Laflin, President and CEO of the company, said, "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. INIS has long established itself as a reliable supplier of radiochemicals and we have earned a reputation for high quality products and excellent customer service. Extending our reach to provide FDA approved products is a logical extension of our current supply arrangements. INIS has several additional products at various stages of development in our pipeline. With the successful FDA approval of our first pharmaceutical product, we look forward to utilizing SODIUM IODIDE I-131 as a springboard to advance additional products we have under development. 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."