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Spotlight on CDER Science


Spotlight on CDER Science

Real-world Evidence from a Narrow Therapeutic Index Product (Levothyroxine) Reflects the Therapeutic Equivalence of Generic Drug Products

The National Institute of Diabetes and Digestive and Kidney Diseases reports that almost 5% of the U.S. population above the age of 12 years have hypothyroidism, a condition characterized by insufficient hormonal output by the thyroid gland. This prevalence of disease carries economic implications for the health care sector. Levothyroxine is the most commonly prescribed thyroid hormone medicine used to treat hypothyroidism and is one of the most widely prescribed drug products in the United States. Given this high prescription rate, the FDA approval of multiple generic products has provided patients with additional options for filling levothyroxine prescriptions and has reduced health care costs for millions of patients.1

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