Archive · 7 Jun 2025
Lupin Receives US FDA Nod for Oxcarbazepine ER Tablets
Lupin, a drug company, has received a tentative approval from the US FDA for a drug called Oxcarbazepine ER tablets.
This is like getting a green light to sell a generic version of another company's medicine used to treat seizures.
The drug is made in India.
The existing drug it's similar to made about $206 million in sales last year.
Lupin's sales went up in some areas and down in others.
Overall, Lupin made more money compared to last year.
The company's profits increased significantly, especially in North America.
The company's stock price changed slightly.
Lupin received tentative US FDA approval for Oxcarbazepine ER tablets.
The drug is a generic equivalent of Supernus Pharmaceuticals' Oxtellar XR.
The drug is used to treat partial-onset seizures in patients aged six and above.
The product will be manufactured at Lupin’s Nagpur facility in India.
Lupin's profit of ₹794.86 crore was higher than expectations.
- Who
- Lupin Ltd.
- What
- Lupin received tentative FDA approval for Oxcarbazepine ER tablets.
- When
- June 7
- Where
- U.S. and India
- Why
- To treat partial-onset seizures and expand Lupin's market.
- Drug Approval
- Oxcarbazepine Extended-Release (ER) Tablets in 150 mg, 300 mg, and 600 mg strengths
- Company
- Lupin Ltd
- Approving Agency
- US FDA
- Manufacturing Location
- Nagpur, India
- Drug Use
- Partial-onset seizures in patients aged six and above
- Comparable Drug Sales
- $206 million (annual US sales, April 2025)
- Lupin's Profit
- ₹794.86 crore