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Are thyroid medicines being taken off the market?

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.

The manufacturers that produce Levoxyl and Unithroid have already applied for and received approval from the FDA. Abbott Laboratories, the maker of Synthroid will be submitting a NDA in accordance with FDA guidelines. If Synthroid is not approved before August 14, 2001 the FDA can ask for the drug to be removed from the market. However, the FDA is likely to allow Synthroid to remain on the market during the approval process.

Sources:
Adams, Chris. “FDA Could Make Abbott Pull Popular Thyroid Drug From The Market.” The Wall Street Journal. Dow Jones & Company, Inc. 2001.
Abbott Response to News Reports on Synthroid. Press Release. Abbott Laboratories. 2001.
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 6/8/01.

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