Lupin has received approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Phytonadione Injectable Emulsion, 1 mg/0.5 mL, in a single-dose prefilled syringe.
The product has been approved as bioequivalent to the reference listed drug (RLD), Phytonadione Injectable Emulsion, 1 mg/0.5 mL, marketed by International Medication Systems. It is indicated for the treatment and prevention of hypoprothrombinemia, a condition characterised by reduced blood-clotting ability, and vitamin K deficiency.
According to IQVIA data, the product recorded estimated annual sales of USD 52.3 million in the US for the 12 months ended August 2026.
The approval follows Lupin’s recent launch of Formoflo-G MDI in India after receiving approval from the Drugs Controller General of India (DCGI). The company describes it as the world’s first fixed-dose triple-combination metered-dose inhaler (MDI) for chronic obstructive pulmonary disease (COPD).
Formoflo-G MDI combines glycopyrronium bromide, formoterol fumarate and fluticasone propionate for the long-term management of moderate to severe COPD. The product is available as a single-strength formulation for twice-daily administration.
Lupin said the launch aims to address treatment needs of millions of people living with COPD in India, a condition that remains a leading cause of death and disability.
Commenting on the launch, Nilesh Gupta, Managing Director, Lupin, said, “As respiratory diseases continue to impact millions across India, access to effective therapies remains critical. Formoflo-G MDI reflects our commitment to addressing unmet patient needs through differentiated, high-quality therapies. By combining innovation with accessibility, we aim to improve outcomes for patients living with respiratory diseases.”
Rajeev Sibal, president – India Region Formulations, Lupin, added that Formoflo-G MDI strengthens Lupin’s respiratory portfolio and provides healthcare professionals with an important treatment option for appropriate COPD patients.
