Lupin gets U.S. FDA tentative approval for Generic Oxcarbazepine ER Tablets
These tablets are the generic equivalent of Oxtellar XR® ER Tablets by Supernus Pharmaceuticals and are indicated for the treatment of partial-onset seizures in patients aged 6 years and above. Lupin's version of the drug will be manufactured at its Nagpur facility in India.
According to IQVIA MAT April 2025 data, Oxcarbazepine ER Tablets (RLD Oxtellar XR®) recorded estimated annual sales of USD 206 million in the United States, underscoring the potential market opportunity for Lupin.
Headquartered in Mumbai, Lupin is a leading global pharmaceutical company with a strong footprint in the U.S. and India. The company focuses on a broad range of therapy areas including central nervous system disorders, respiratory, cardiovascular, anti-infective, and women's health. It operates 15 manufacturing sites and 7 research centers globally, supported by over 23,000 employees.
Lupin continues to expand its U.S. portfolio of complex generics and remains committed to delivering high-quality, affordable medicines that improve health outcomes for patients around the world.
Aman Shukla is a post-graduate in mass communication . A media enthusiast who has a strong hold on communication ,content writing and copy writing. Aman is currently working as journalist at BusinessUpturn.com
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