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).
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