Alembic Pharmaceuticals Receives USFDA Final Approval for Phytonadione Injectable Emulsion
Alembic Pharmaceuticals Limited has announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) 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 (RLD), Phytonadione Injectable Emulsion USP, 1 mg/0.5 mL, of International Medication Systems Limited. Phytonadione Injectable Emulsion is indicated for the treatment of hypoprothrombinemia due to vitamin K deficiency or interference and for prophylaxis and treatment of vitamin K-deficiency bleeding in neonates. The product has an estimated market size of US$ 44 million for twelve months ending June 2025 according to IQVIA.
Key Highlights
- Alembic Pharmaceuticals receives USFDA final approval 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 (RLD), Phytonadione Injectable Emulsion USP, 1 mg/0.5 mL, of International Medication Systems Limited.
- Phytonadione Injectable Emulsion is indicated for the treatment of hypoprothrombinemia due to vitamin K deficiency or interference and for prophylaxis and treatment of vitamin K-deficiency bleeding in neonates.
- The product has an estimated market size of US$ 44 million for twelve months ending June 2025 according to IQVIA.
- Alembic Pharmaceuticals has a cumulative total of 225 ANDA approvals (204 final approvals and 21 tentative approvals) from USFDA.