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FDA approves new indication for Thyrogen
Genzyme Corp. has received word from the FDA that its recombinant form of thyroid stimulating hormone (TSH), thyrotropin alfa (Thyrogen), can now be used in conjunction with radioiodine for destruction of remaining thyroid tissue following surgical removal of the gland in patients with thyroid cancer. The therapy raises the level of TSH necessary for proper uptake of the radioiodine used to ablate the thyroid tissue. Before this approval, patients had to discontinue their thyroid hormone supplements in order to naturally elevate their TSH level, but often suffered the side effects associated with hypothyroidism. Thyrogen was originally approved in 1998 as an adjunctive diagnostic tool for serum thyroglobulin testing in patients with thyroid cancer who had their thyroid gland removed.