Received FDA approval for its ANDA for Levocarnitine Oral Solution

Saptalis Pharmaceuticals, LLC announced today that it has received FDA approval for its ANDA for Levocarnitine Oral Solution 1gm/10mL. Levocarnitine is indicated in the treatment of primary systemic carnitine deficiency. The product is also indicated for acute and chronic treatment of patients with an inborn error of metabolism which results in a secondary carnitine deficiency. Levocarnitine Oral Solution is a generic equivalent of Carnitor ® Oral Solution, Leadiant Biosciences, Inc. The product has annual sales of $12M (IQVIA). The Company will commercialize the product in collaboration with its marketing & distribution partner, TruPharma, LLC.

The release as fetched from its publisher. saptalis.com ↗