Lupin Ltd has received approval from the US Food and Drug Administration (US FDA) for its Abbreviated New Drug Application (ANDA) for Phytonadione Injectable Emulsion USP, 1 mg/0.5 mL Single-dose Prefilled Syringe.
The US FDA has approved Lupin’s product as bioequivalent to the reference listed drug, Phytonadione Injectable Emulsion, 1 mg/0.5 mL, marketed by International Medication Systems.
The drug is used to treat and prevent low blood clotting caused by hypoprothrombinemia and vitamin K deficiency.
Phytonadione Injectable Emulsion had estimated annual sales of $52.3 million in the US, according to IQVIA MAT August 2026 data.
Lupin’s other US FDA approval
In a separate development, Lupin announced on August 10 that it had received US FDA approval for its ANDA for Sodium Zirconium Cyclosilicate for Oral Suspension in 5 g/packet and 10 g/packet strengths.
The US FDA approved Lupin’s product as bioequivalent to Lokelma for Oral Suspension, the reference listed drug of AstraZeneca Pharmaceuticals LP.
The drug is indicated for the treatment of high potassium levels in the blood, or hyperkalemia, in adults.
Lupin shares closed at ₹1,947 on October 8, down 3.27%.