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Genzyme General's Thyrogen

This article was originally published in The Gray Sheet

Executive Summary

Recombinant human thyroid stimulating hormone is recommended for approval by FDA's Endocrinologic and Metabolic Drugs Advisory Committee May 15 by an 8-3 vote for use in conducting thyroid scanning and thyroglobulin testing in cancer patients who have had part or all of their thyroid gland removed and who would benefit from the avoidance of hypothyroidism. The panel also votes 11-0 to recommend approval for use in patients who otherwise would be examined solely with a serum thyroglobulin test without undergoing withdrawal from hormone supplements. The company estimates that U.S. physicians order roughly 135,000 thyroglobulin tests each year for patients who have had thyroid cancer, and a that similar number are performed in Europe annually...
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