FDA has approved the first New Drug Application (NDA) for the thyroid hormone replacement drug, levothyroxine sodium (Unithroid) for use in adults and children. In children, thyroid hormones are essential for normal physical growth and intellectual development. They are also involved in the regulation of a wide range of metabolic processes within the body in all age groups.
Although oral levothyroxine drugs products have been marketed in the United States since the 1950’s, the approval of Unithroid represents the first time that a single ingredient oral levothryoxine product has been approved by the FDA. The unapproved thyroid hormone replacement products that have been on the market have been associated with stability and potency problems. These problems have resulted in product recalls and have the potential to cause serious health consequences to the public. With the approval of the NDA for Unithroid, patients and physicians now have available to them an oral levothryroxine sodium drug product that has been determined to be safe and effective by the FDA and that also meets FDA standards for manufacturing processes, purity, potency, and stability.