Lupin gets tentative approval for Ivacaftor Tablets from USFDA

08 Jun 2022 Evaluate

Lupin has received tentative approval from the United States Food and Drug Administration (USFDA) 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 $109 million in the U.S. 

Lupin is an innovation led transnational pharmaceutical company producing, developing and marketing a wide range of branded and generic formulations, biotechnology products and active pharmaceutical ingredients (APIs) globally.

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2168.00 -8.25 (-0.38%)
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