Milla Pharmaceuticals, a subsidiary of the Alter Pharma Group, announced that it has received abbreviated new drug application (ANDA) approval from the U.S. Food and Drug Administration (FDA) for its generic version of Sodium Acetate Injection 2MEQ/mL
Milla Pharmaceuticals was previously granted a Competitive Generic Therapy (CGT) designation for its generic drug by the FDA, which is indicated as a source of sodium for addition to large volume intravenous fluids to prevent or correct hyponatremia in patients with restricted or no oral intake. It is also used as an additive for preparing specific intravenous fluid formulas when the needs of the patient cannot be met by standard electrolyte or nutrient solutions.
As the first approved application, on July 7th, 2021, Milla Pharmaceuticals has established its first commercial sale through its exclusive partner, Woodward Pharma Services LLC, thus securing 180-days of market exclusivity. The FDA has recently listed Sodium Acetate Injection 2MEQ/mL on their FDA Drug Shortages List.