A.forall announced through its U.S. subsidiary, Milla Pharmaceuticals, 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.
“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”
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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.
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“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.
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Source – businesswire
