Latest news with #OxcarbazepineERTablets
United News of India
2 hours ago
- Business
- United News of India
Lupin gets tentative approval from U.S. FDA for Oxcarbazepine ER Tablets
Hyderabad, June 7 (UNI) Global pharma major Lupin Limited (Lupin) announced on Saturday 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, the Pharma company said in a release. 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). UNI KNR BM
Business Upturn
a day ago
- Business
- Business Upturn
Lupin gets U.S. FDA tentative approval for Generic Oxcarbazepine ER Tablets
Lupin Limited has announced that it has received tentative approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Oxcarbazepine Extended-Release (ER) Tablets in 150 mg, 300 mg, and 600 mg strengths. 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
