A.forall Announces Launch of a Generic Version of Sodium Acetate Injection 4 mEq/mL
09 Jan 2024
Priority ReviewDrug ApprovalBreakthrough Therapy
Preview
Source: Business Wire
'Our joint mission of making affordable medicines available to all is more then ever at the centre of what we do every day'
Preview
Source: Business Wire
MINNETONKA, Minn.--(BUSINESS WIRE)--Milla Pharmaceuticals Inc., an A.forall company, announced that its partner, Woodward Pharma Services LLC, has just commercialized its Supplemental Abbreviated New Drug Application (sANDA) approval from the U.S. Food and Drug Administration (FDA) for a generic version of Sodium Acetate Injection 4 mEq/mL marketed by Fresenius Kabi USA LLC.
Sodium Acetate Injection 4 mEq/mL 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.
Milla Pharmaceuticals was previously granted a Competitive Generic Therapy (CGT) designation for its generic drug product, Sodium Acetate Injection, 2 mEq/mL, by the FDA in 2021, which has been commercialized since July 2021. The newly launched 4 mEq/mL is a more concentrated version marketed by Fresenius Kabi USA LLC.
The approval of this Supplemental Abbreviated New Drug Application (sANDA), which occurred under priority review from the FDA because of its shortage status, has been consistent with A.forall’s last two FDA filings which were First Cycle Review Approvals. The Sodium Acetate Injection 4 mEq/mL has been consistently listed on the FDA Drug Shortages List for the last several years.
“Our joint mission of making affordable medicines available to all is more then ever at the centre of what we do every day,” commented Filip Van de Vliet, CEO of A.forall. “With this sANDA, an alternative concentration of the Sodium Acetate Injection we launched two years ago, we again substantially increase the availability of a life-saving drug that U.S. patients would otherwise be lacking. Once again, the strength of our product development and regulatory teams has allowed us to bring a fast and high-quality solution to those in need.”
About A.forall
We Make Affordable Medicines Available To All: we develop value-added generic pharmaceuticals, solve product shortages and fill unmet medical needs so that patients can continue their treatment.
At the same time, we are reducing costs to the healthcare system and increasing customer convenience for a more sustainable world.
More info: About – A.forall
About Milla Pharmaceuticals
Milla Pharmaceuticals Inc., an A.forall company, 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
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
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