Lupin receives tentative approval from U.S. FDA for Ivacaftor Tablets

Global pharma major Lupin Limited (Lupin) today announced that it has received tentative approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) Ivacaftor Tablets, 150 mg, to market a generic equivalent of Kalydeco® Tablets, 150 mg of Vertex Pharmaceuticals Incorporated. This product will be manufactured at Lupin's Nagpur facility in India.

Ivacaftor Tablets (RLD: Kalydeco® Tablets) had estimated annual sales of USD 109 million in the U.S. (IQVIA MAT March 2022).

Shares of Lupin Limited was last trading in BSE at Rs. 609.90 as compared to the previous close of Rs. 604.20. The total number of shares traded during the day was 36116 in over 1471 trades.

The stock hit an intraday high of Rs. 611.00 and intraday low of 598.10. The net turnover during the day was Rs. 21847203.00.

Source : Equity Bulls

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Lupin INE326A01037 USFDA ANDA IvacaftorTablets TentativeApproval