FDA Warns Int’l Isotopes Over Unapproved Thyroid Drug

Law360, New York (November 10, 2011, 6:00 PM EST) -- The U.S. Food and Drug Administration has warned International Isotopes Inc. for marketing an unapproved drug used to treat thyroid disorders and for significant violations of good manufacturing practices at its Idaho plant, according to an FDA letter released Tuesday.

During a July inspection at International Isotopes' Idaho Falls plant, FDA inspectors said they discovered the company was manufacturing a radiopharmaceutical called sodium iodide I-131 without the FDA's authorization. The radiopharmaceutical is used in medicine that treats multiple thyroid diseases and disorders, according to the International...
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