WHITE BEAR LAKE, Minn.--(BUSINESS WIRE)--A.forall announced through its U.S. subsidiary, Milla Pharmaceuticals Inc., that it has received Abbreviated New Drug Application (ANDA) approval by the U.S. Food and Drug Administration (FDA) for a generic version of THAM Solution Tromethamine Injection 18GM/500mL marketed by Hospira Inc, a Pfizer company.
Tromethamine Injection is indicated for prevention and correction of metabolic acidosis.
This marks the 6th overall ANDA approval for A.forall and another instance where Competitive Generic Therapy (CGT) eligibility has been granted. Moreover, Milla Pharmaceuticals is commercializing Tromethamine Injection using their own label and their expanded US market presence, offering more direct access to customers and patients.
“As this product was previously reported in shortage in the U.S. for multiple years, the approval and launch of Tromethamine Injection reinforce our mission of making affordable medicines available to all, by continuing the expansion of high-quality generic injectables supply throughout and beyond the U.S. market,” commented Erik Lazarich, A.forall’s President of U.S. Operations.
Commercialization is currently underway, with a 180-day exclusivity as from launch.
Please see link for Full Prescribing Information.
About A.forall & Milla Pharmaceuticals
At A.forall, our mission is all about Making 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.
Milla Pharmaceuticals Inc., the U.S. subsidiary of A.forall, is engaged in the development, licensing, acquisition, and commercialization of generic prescription drugs for the U.S. market, focusing on niche injectable and solution products for hospitals and clinics.
More info: About – A.forall & About - Milla Pharmaceuticals
Contacts
Erik Lazarich
Milla Pharmaceuticals Inc.
1310 Highway 96 E, Suite 104A
White Bear Lake, MN 55110-3618
+1 (952) 449-5154
