Lupin Receives Tentative Approval from U.S. FDA for Oxcarbazepine ER Tablets
Mumbai, Naples, June 7, 2025: Global pharma major Lupin Limited (Lupin) today announced that it has received tentative approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Oxcarbazepine Extended-Release (ER) Tablets, 150 mg, 300 mg, and 600 mg. This product would be manufactured at Lupin’s Nagpur facility in India.
Oxcarbazepine ER Tablets, 150 mg, 300 mg, and 600 mg are bioequivalent to Oxtellar XR® ER Tablets, 150 mg, 300 mg, and 600 mg, of Supernus Pharmaceuticals, Inc., and are indicated for the treatment of partial onset seizures in patients 6 years of age and older.
Oxcarbazepine ER Tablets (RLD Oxtellar XR®) had estimated annual sales of USD 206 million in the U.S. (IQVIA MAT April 2025).
About Lupin
Lupin Limited is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets. Lupin specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. Trusted by healthcare professionals and consumers globally, the company enjoys a strong position in India and the U.S. across multiple therapy areas, including respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women's health. Lupin has 15 state-of-the-art manufacturing sites and 7 research centers globally, along with a dedicated workforce of over 23,000 professionals. Lupin is committed to improving patient health outcomes through its subsidiaries - Lupin Diagnostics, Lupin Digital Health, and Lupin Manufacturing Solutions.
To know more, visit www.lupin.com or follow us on LinkedIn https://www.linkedin.com/company/lupin
For further information or queries please contact –
Rajalakshmi Azariah
Vice President & Global Head – Corporate Communications, Lupin
rajalakshmiazariah@lupin.com
*Safe Harbor Statement
Oxtellar XR® is a registered trademark of Supernus Pharmaceuticals, Inc.
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