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Draxis: FDA approves sodium iodide I-131 capsules for thyroid function tests
By E. Janene Geiss
Philadelphia, Jan. 13 - Draxis Health Inc.'s radiopharmaceutical business unit said it has received approval from the Food and Drug Administration for its supplemental new drug application for sodium iodide I-131 capsules.
The I-131 capsules are intended to be used by physicians to perform the radioactive iodide uptake test to evaluate thyroid function prior to treatment with stronger therapeutic doses of sodium iodide I-131, according to a company news release.
Diagnostic doses of sodium iodide I-131 also may be employed in localizing metastases associated with thyroid malignancies, officials said.
The diagnostic capsules, which are supplied in a gelatin capsule for oral administration, will be produced by Draximage, a division of Draxis Specialty Pharmaceuticals Inc., the Montreal-based subsidiary that serves as the operating arm of Draxis Health Inc.
Draximage said it plans to introduce the new diagnostic capsules into the U.S. market during the first half of 2006, targeting qualified, approved nuclear physicians and/or radiopharmacists.
The capsules will be supplied in several different strengths of radioactivity. Draximage said it will employ a system of color coding to allow each patient to be administered the precise dose of radioactive iodine prescribed by their physician.
The capsules are a further addition to the existing line of I-131 radiopharmaceutical products produced by Draximage, including its widely used kit for the preparation of sodium iodide I-131 capsules and oral solution for the treatment of thyroid cancer and hyperthyroidism.
The FDA-approved kit product for therapeutic use was introduced to the U.S. market in 2003, officials said.
Mississauga, Ont., Draxis Health, through its wholly owned operating subsidiary, Draxis Specialty Pharmaceuticals Inc., provides sterile products, non-sterile products and radiopharmaceuticals.
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