Lupin receives approval from U.S. FDA for Vigabatrin for Oral Solution USP

Global pharma major Lupin Limited (Lupin) today announced that it has received approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA), Vigabatrin for Oral Solution USP, 500 mg to market a generic equivalent of Sabril® for Oral Solution, 500 mg of Lundbeck Pharmaceuticals, LLC. The product will be manufactured at Lupin's facility in Goa, India.

Vigabatrin for Oral Solution USP, 500 mg (RLD Sabril®) had estimated annual sales of USD 275 million in the U.S. (IQVIA MAT December 2021).

Shares of Lupin Limited was last trading in BSE at Rs. 748.15 as compared to the previous close of Rs. 739.40. The total number of shares traded during the day was 50712 in over 1307 trades.

The stock hit an intraday high of Rs. 754.70 and intraday low of 739.35. The net turnover during the day was Rs. 37904042.00.

Source : Equity Bulls

Keywords

Lupin INE326A01037 USFDA ANDA Approval Vigabatrin OralSolution