Milla Pharmaceuticals has recently announced that it has received Abbreviated New Drug Application (ANDA) approval from the Food and Drug Administration (FDA) for its generic version of Sodium Acetate injection, according to Valdosta Daily Times.
A subsidiary of the Alter Pharma Group, Milla Pharmaceuticals was previously granted a Competitive Generic Therapy (CGT) designation for its generic version of Sodium Acetate infection by the FDA.
Sodium acetate injection is indicated in patients with hypernatremia (low sodium levels). It is given intravenously to prevent or correct hyponatremia in patients with restricted or no oral intake.
In July, Milla Pharmaceuticals established its first commercial sale through its exclusive partner, Woodward Pharma Services LLC, securing 180-days of market exclusivity.
Woodward President Nirav Patel said, “Woodward Pharma Services LLC is excited to partner with Milla Pharmaceuticals to offer Sodium Acetate as part of Woodward’s growing hospital product portfolio.”
Filip Van de Vliet, CEO of the Alter Pharma Group, said, “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, thereby demonstrating the quite unique capabilities of our R&D and regulatory teams and partners to realize a first-cycle approval.”
Milla Pharmaceuticals is engaged in the development, licensing/acquisition, and commercialization of generic prescription drugs for the U.S. market. It is focused on niche injectable and solution products for hospitals and clinics.
The company’s goal is to deliver high-quality medicines at affordable prices by leveraging global partnerships with FDA-approved manufacturing facilities from around the world.
Woodward Pharma Services LLC is a specialty pharma company focused on acquiring, licensing, and commercializing branded and generic prescription drugs for the U.S. Market. The article appeared in Valdosta Daily Times.
