Endocrinology

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FDA Action Creates Concern About Supply of Levothyroxine Products

KEY POINT

Health professionals and consumers remain confused and concerned about the adequacy of levothyroxine supplies, following an FDA action earlier this summer that directed manufacturers of unapproved levothyroxine products to reduce distribution while they await approval of new drug applications (NDAs). This group includes market leader Synthroid, but Abbott Laboratories assures the public that it anticipates FDA approval before supplies dwindle.

SOURCES

Guidance for industry. Levothyroxine sodium products enforcement of August 14, 2001 compliance date and submission of new applications. Center for Drug Evaluation and Research. U.S. Food and Drug Administration.