Regulatory9 Oct 2026 · Thu evening
LUPINLupin
Lupin gets US approval for a vitamin K injection
Lupin received US FDA approval for Phytonadione Injectable Emulsion in a single-dose prefilled syringe. The reference product had US sales of about $52.3 million a year.
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- Sector
- Pharmaceuticals
What happened
- Lupin said the US Food and Drug Administration approved its Phytonadione Injectable Emulsion USP, 1 mg per 0.5 mL, in a single-dose prefilled syringe.
- The approval is for an abbreviated new drug application, with the product established as bioequivalent to the reference listed drug marketed by International Medication Systems.
- The company cited estimated annual US sales of $52.3 million for Phytonadione Injectable Emulsion, on IQVIA MAT data for August 2026.
- Phytonadione is a form of vitamin K, used where blood clotting is impaired.
- The shares closed at ₹1,936.90 on Thursday, down 3.78%.
Why it matters
Good to know: An abbreviated new drug application is the route for a generic version of an already-approved medicine. The sales figure describes the existing US market for that medicine, not Lupin's own expected sales.
Key facts
- Product
- Phytonadione Injectable Emulsion USP, 1 mg/0.5 mL
- Form
- Single-dose prefilled syringe
- Reference product US sales
- About $52.3 million a year
- Source of estimate
- IQVIA MAT, August 2026
Read the source
This is a summary of public news about Lupin, for information only. It is not a recommendation to buy, sell or hold LUPIN.