Home » Drug Information » FDA Approved Drugs » 2001
Medical Areas: Endocrinology
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The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Company: Jones Pharma
Approval Status: Approved May 2001
Treatment Area: Thyroid disease; Hypothyroidism
Levoxyl has been approved for use as a replacement therapy for
any form of diminished or absent thyroid function and as a means of
suppressing pituitary secretion of TSH in euthyroid subjects to
treat or prevent goiters. Levoxyl is available in tablet
formulation, in 12 different color-coded strengths.
About 20 million Americans suffer from some form of thyroid
disease and over 13 million subjects in the United States rely on
hormone replacement therapy, which is usually taken for life, for
Levoxyl has been prescribed as a thyroid hormone replacement
therapy for the past 13 years. Due to an FDA ruling in 1997, all
companies manufacturing levothyroxine sodium drugs were required to
submit new drug applications in order to continue marketing these
Adverse events associated with the use of levothyroxine sodium
may include (but are not limited to) the following:
- Overdose may induce hyperthyroidism
- Skin rash or hives
- Weight gain or loss
Mechanism of Action
Levoxyl contains synthetic crystalline levothyroxine sodium,
which is the principal hormone secreted by the thyroid gland.
Thyroid hormones are designed to regulate the metabolic rate of
most body tissues.
For additional information on Levoxyl, please visit