December 15, 2020
The U.S. FDA has approved Thyquidity™ (levothyroxine) oral solution, manufactured by VistaPharm, to provide replacement therapy for primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. In addition, the agency has approved Thyquidity as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well- differentiated thyroid cancer.
Thyquidity is a new oral solution formulation of levothyroxine, which is a current standard of care in the treatment of hypothyroidism and thyroid cancer. Levothyroxine is used to replace missing thyroid hormone that, under normal circumstances, the body produces naturally. In hypothyroidism, the body doesn’t produce enough thyroid hormones because the thyroid gland isn’t as active as it should be. For patients who have thyroid cancer, thyroid hormone replacement therapy may be necessary if the thyroid gland has been removed to treat the disease.
Recommended dosing is based on a variety of factors that include the patient’s age, body weight, cardiovascular status, concomitant medical conditions, concomitant medications, co-administered food, and the condition being treated. Patients should receive periodic monitoring of thyroid hormone levels and their clinical status. A black box warning cautions that thyroid hormones like Thyquidity should not be used to treat obesity or for weight loss, and that doses of Thyquidity beyond the range of a patient’s daily hormonal requirements may cause serious or life-threatening toxicity.
Launch and pricing information are not yet available.