– Company granted 180-days of exclusivity under FDA Competitive Generic Therapy approval pathway –
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.
“Woodward Pharma Services LLC is excited to partner with Milla Pharmaceuticals to offer Sodium Acetate as part of Woodward’s growing hospital product portfolio” said Nirav Patel, President of Woodward Pharma Services LLC.
This achievement marks a milestone for Milla Pharmaceuticals and the Alter Pharma Group not only as their first ANDA approval but also as a first-cycle review approval and garnering FDA’s coveted CGT Exclusivity. “After the launch by Sandoz of our generic injectable acetaminophen (paracetamol IV) in December 2020, being the first Alter Pharma product hitting the US market, this is another important step in our mission to make affordable and high-quality medicines available to all,” commented Filip Van de Vliet, CEO of the Alter Pharma Group, “thereby demonstrating the quite unique capabilities of our R&D and regulatory teams and partners to realize a first-cycle approval”.
About Milla Pharmaceuticals
Milla Pharmaceuticals is engaged in the development, licensing / acquisition and commercialization of generic prescription drugs for the U.S. market focused on niche injectable and solution products for hospitals and clinics.
More info: About – Milla Pharmaceuticals
About Woodward Pharma Services LLC
Woodward Pharma Services LLC is a specialty pharmaceutical company focused on acquiring, licensing, and commercializing branded and generic prescription drugs for the U.S. Market. Woodward has a diverse portfolio of products distributed across multiple channels.
More info: Who We Are — Woodward Pharma Services LLC
Contact for Milla Pharmaceuticals:
Contact for Woodward Pharma Services
Nirav Patel T: +1 (248) 308-1120 nirav.patel@woodwardpharma.com
Source: Milla Pharmaceuticals
