Sigma-Tau’s Carnitor (levocarnitine) injection
Executive Summary
Supplemental NDA approved Dec. 16 "for the acute and chronic treatment of patients with an inborn error of metabolism that results in a secondary carnitine deficiency." With the approval, Carnitor gets seven years of orphan drug marketing exclusivity. Carnitor tablets and oral solution are approved for the treatment of primary systemic carnitine deficiency.