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Are thyroid medicines being taken off the market?

Thyroid medicines containing levothyroxine sodium are not being taken off the market. Levothyroxine sodium products went on the market more than four decades ago. Like some other drugs that were marketed before 1962, they never received formal approval from the Food and Drug Administration (FDA).

Currently, all drugs being evaluated by the FDA are required to submit New Drug Applications (NDAs). The FDA has recently required the makers of levothyroxine products to submit a NDA, in order to receive formal approval. The products affected are Synthroid, >Levoxyl, >Levothroid, Unithroid, and all generic forms of levothyroxine sodium. These levothyroxine sodium products all had their New Drug Applications approved by July 2002.

Sources:
Abbott Response to News Reports on Synthroid. Press Release. Abbott Laboratories. 2001.
Adams, Chris. “FDA Could Make Abbott Pull Popular Thyroid Drug From The Market.” The Wall Street Journal. Dow Jones & Company, Inc. 2001.
Approved Drug Products with Therapeutic Equivalance Evaluations, 26th ed. U.S. Department of Health and Human Services, 2006.Food and Drug Administration. Department of Health and Human Services. Letter to Knoll Pharmaceutical Company. Docket No. 97N-0314/CP2. April 26, 2001.
Food and Drug Administration. Talk Paper. “FDA Approves First NDA for Levothyroxine Sodium.” August 22, 2000.

This answer prepared 6/8/2001.
This information updated 1/23/2007.

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