International Isotopes Inc.

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» Sodium Iodide I-131

International Isotopes Inc. has submitted an abbreviated new drug application (aNDA) to the U.S. Food and Drug Administration (FDA) for its Sodium Iodide I-131 radiopharmaceutical product.  This is the first application submitted to the FDA by any company for a generic sodium iodide product, and the FDA has indicated they will complete an expedited review of the aNDA.

For many decades sodium iodide has proven itself to be an essential product for the treatment and diagnosis of diseases of the thyroid, thyroid cancer, and hyperthyroidism and for use in investigational and clinical trials for the treatment of breast, lung, prostate, and ovarian cancers. We believe that, if approved, our Sodium Iodide I-131 product will offer numerous distinct advantages to patients, pharmacies, and hospitals.

Advantages include:

» Cobalt and Radiochemical Products

We bring the benefits of nuclear technology to a wide variety of medical and industrial applications. Our cobalt products are used by a broad array of companies for radiation treatment of cancer and vascular deformities of the brain. Cobalt sources are also used for container security examinations at our sea ports and borders. Our radiochemicals, such as Iodine-131, are used in a variety of chemical, industrial and medically related applications.

» Nuclear Medicine Calibration Standards

Calibration standards are used for a range of applications in nuclear pharmacy from testing of imaging machines to calibration of patient dose measurement devices. These products help ensure that nuclear medicine pharmacies, procedures, and devices perform as intended to offer safe and effective patient treatment, therapy, or imaging. We are a contract manufacturer to RadQual LLC for many of these products. Please visit their website for more information.