Alembic Pharmaceuticals Limited has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Phytonadione Injectable Emulsion USP, 1 mg/0.5 mL Single-Dose Prefilled Syringe. The approved ANDA is therapeutically equivalent to the reference listed drug product, Phytonadione Injectable Emulsion USP, 1 mg/0.5 mL, marketed by International Medication Systems Limited.
Phytonadione Injectable Emulsion is used to treat hypoprothrombinemia caused by vitamin K deficiency or interference and is also indicated for the prevention and treatment of vitamin K-deficiency bleeding in neonates. The product label provides full details of its indications. According to IQVIA, the market for Phytonadione Injectable Emulsion USP, 1 mg/0.5 mL Single-Dose Prefilled Syringe, is estimated at US$ 44 million for the twelve months ending June 2025, highlighting its commercial potential in the US generics market.
With this approval, Alembic has achieved a cumulative total of 225 ANDA approvals from the USFDA, including 204 final approvals and 21 tentative approvals, reflecting its strong track record in regulatory compliance and generic drug development.
