FDA cleared the first generic sodium iodide product to treat hyperthyroidism and carcinoma of the thyroid.
International Isotopes Inc. recently announced in a press release it received approval for its Sodium Iodide I-131 pharmaceutical product, a radioactive therapeutic agent.
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It plans to distribute the product commercially in the near future.
There is a potentially lucrative market for the new treatment, since the American Cancer Society estimates more than 50,000 adults in the U.S. are diagnosed with thyroid cancer each year.
"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 US,” says Steve T. Laflin, president and CEO of International Isotopes.
The pharma maker has several additional products at various stages of development in is pipeline, Laflin noted.
“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,” he adds.
Radiochemical Sodium Iodide I-131 is utilized for the preparation of sodium iodide I-131 capsules and solution.
To use Sodium Iodide I-131 safely and effectively, the company urges healthcare providers to “see the full prescribing information for Sodium Iodide I-131 included in product labeling as well as all warnings, precautions, possible adverse reactions, and drug interactions.”