Alembic Pharma gets USFDA nod for Phytonadione Injectable Emulsion for hypoprothrombinemia due to vitamin K deficiency
Vadodara:Alembic Pharmaceuticals Limitedhas announced that the company 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 tovitamin Kdeficiency or interference. It is also indicated for prophylaxis and treatment of vitamin K-deficiency bleeding in neonates. Phytonadione Injectable Emulsion USP, 1 mg/0.5 mL Single-Dose Prefilled Syringe, have an estimated market size of US$ 44 million for twelve months ending June 2025 according to IQVIA. Alembic has a cumulative total of 225 ANDA approvals (204 final approvals and 21 tentative approvals) from USFDA. Read also:Alembic Pharma gets USFDA nod for anticonvulsant drug Carbamazepine Extended Release Read also:Alembic Pharma wins USFDA approval for pulmonary arterial hypertension drug Macitentan
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