Lupin receives Tentative Approval from U.S. FDA for Dolutegravir Tablets for Oral Suspension

Global pharma major Lupin Limited (Lupin) today announced that it has received tentative approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA), Dolutegravir Tablets for Oral Suspension, 5 mg, to market a generic equivalent of Tivicay PD® Tablets for Oral Suspension, 5 mg of ViiV Healthcare Company. This product will be manufactured at Lupin's Nagpur facility in India.

Dolutegravir Tablets for Oral Suspension (RLD Tivicay PD®) had estimated annual sales of USD 1 million in the U.S. (IQVIA MAT March 2023).

Shares of Lupin Limited was last trading in BSE at Rs. 890.90 as compared to the previous close of Rs. 892.45. The total number of shares traded during the day was 34839 in over 2066 trades.

The stock hit an intraday high of Rs. 902.00 and intraday low of 885.55. The net turnover during the day was Rs. 31188117.00.

Source : Equity Bulls

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Lupin INE326A01037 TentativeApproval USFDA ANDA DolutegravirTablets