Amphastar granted FDA approval of ANDA for Enoxaparin Sodium Injection 300mg/3mL
Amphastar Pharmaceuticals announced that the U.S. FDA granted approval of its Abbreviated New Drug Application for Enoxaparin Sodium Injection 300mg/3mL Multiple Dose Vial. The company currently manufactures and distributes Enoxaparin Sodium Injection in prefilled syringe form and this approval of the Multiple Dose Vial allows the company to begin offering the full line of Enoxaparin products. Amphastar's newly approved product was determined by the FDA to be therapeutically equivalent to Lovenox MDV sold in the United States by Sanofi-Aventis. Amphastar plans to launch Enoxaparin MDV in the second quarter. According to IQVIA, U.S market annual sales for the 12 months ended December 31, 2018 for Enoxaparin Sodium Injection 300mg/3mL MDV was approximately $11M.