The product is approved to treat primary systemic carnitine deficiency and for patients with an inborn error of metabolism, which causes secondary carnitine deficiency.

Sigma-Tau was previously approved to sell Carnitor in a sugar-containing solution.

"We are pleased to be able to offer a sugar-free version of Carnitor for patients who are diabetic or those who are on a Ketogenic Diet, those who are intolerant or have sensitivities to sugar and develop carnitine deficiency," said Gregg Lapointe, Sigma-Tau chief operating officer.

Primary systemic carnitine deficiency is a rare genetic disorder usually seen in infants, with the secondary form of the disease occurring in infants, children, and adults. The disorder is caused by factors including inborn errors of metabolism, chronic renal dialysis, extreme prematurity, malabsorption or HIV infection. Symptoms of secondary carnitine deficiency include cardiomyopathy, encephalopathy, muscle weakness, anemia, and fatigue.