USFDA7 Jun 2025, 04:54 pm
Lupin Receives Tentative Approval from U.S. FDA for Oxcarbazepine ER Tablets
AI Summary
Global pharma major Lupin Limited has announced that it has received tentative approval from the U.S. FDA for its Abbreviated New Drug Application for Oxcarbazepine Extended-Release (ER) Tablets, 150 mg, 300 mg, and 600 mg. The product will be manufactured at Lupin’s Nagpur facility in India and is bioequivalent to Oxtellar XR® ER Tablets, 150 mg, 300 mg, and 600 mg, of Supernus Pharmaceuticals, Inc. The estimated annual sales of the RLD Oxtellar XR® in the U.S. are USD 206 million (IQVIA MAT April 2025).
Key Highlights
- Lupin Limited receives tentative approval from the U.S. FDA for Oxcarbazepine ER Tablets
- The product is bioequivalent to Oxtellar XR® ER Tablets of Supernus Pharmaceuticals, Inc.
- The ER Tablets are indicated for the treatment of partial-onset seizures in patients 6 years of age and older
- The estimated annual sales of the RLD Oxtellar XR® in the U.S. are USD 206 million (IQVIA MAT April 2025)
- The product will be manufactured at Lupin’s Nagpur facility in India