Lupin receives USFDA tentative approval for Ivacaftor Tablets

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).

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