US FDA approves Sigma-Tau

The US Food and Drug Administration has approved Sigma-Tau Pharmaceuticals' Carnitor SF (levocarnitine) sugar-free oral solution for the same indication cleared for the firm's current Carnitor oral solution containing sugar. Both products are indicated to treat primary systemic carnitine deficiency and for acute and chronic treatment of patients with an inborn error of metabolism which results in a secondary carnitine deficiency. Adverse events reported with Carnitor use include nausea, vomiting, body odor, gastritis and seizures, noted Sigma-Tau.