Thursday, April 9, 2020

Thursday, April 9, 2020

INTERNATIONAL ISOTOPES INC.: Announces U.S. Food And Drug Administration Approval Of Their ANDA For Sodium IODIDE I-131


International Isotopes Inc. issued the following announcement on Feb. 10.

International Isotopes Inc. (OTCQB: INIS) (the "Company") is pleased to announce it has received approval from the U.S. Food and Drug Administration (FDA) 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."

About INIS's Sodium Iodide I-131 Product

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 please 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.

About International Isotopes Inc.

International Isotopes Inc. manufactures a full range of nuclear medicine calibration and reference standards and provides radiochemicals for clinical research and life sciences.  The Company also produces a variety of cobalt-60 products such as teletherapy sources and performs contract manufacturing of select radiopharmaceutical products for clients.

Original source can be found here

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