Lupin Secures US FDA Approval and Launches Brivaracetam Oral Solution

Global pharmaceutical major Lupin Limited has announced the approval and launch of Brivaracetam Oral Solution in the United States following clearance from the U.S. Food and Drug Administration (FDA). The drug, marketed as a generic equivalent to Briviact Oral Solution, is designed to treat partial-onset seizures in pediatric and adult patients.  

Key Highlights

• FDA approval: Lupin received approval for its Abbreviated New Drug Application (ANDA) for Brivaracetam Oral Solution 10 mg/mL.  
• Brivaracetam: Bioequivalent to Briviact Oral Solution of UCB Inc., ensuring therapeutic equivalence.  
• Indication: Approved for treatment of partial-onset seizures in patients aged one month and older.  
• Market potential: The reference drug Briviact recorded estimated annual U.S. sales of USD 135 million, offering Lupin a significant opportunity.  
• Strategic impact: Strengthens Lupin’s neurology portfolio and expands its footprint in the U.S. generics market.  
• Investor note: Lupin’s shares reflected modest gains following the announcement, signaling positive investor sentiment.  

Sources: CNBC TV18, PR Newswire, The Malaysian Reserve