Lupin bags USFDA nod for cystic fibrosis drug Ivacaftor
This product will be manufactured at Lupin’s Nagpur facility in India.
Mumbai: Global pharma major, Lupin Limited, today announced that the company has received tentative approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Ivacaftor Tablets, 150 mg used to treat cystic fibrosis. The product is a generic equivalent of Kalydeco Tablets, 150 mg of Vertex Pharmaceuticals Incorporated. This product...
Mumbai: Global pharma major, Lupin Limited, today announced that the company has received tentative approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Ivacaftor Tablets, 150 mg used to treat cystic fibrosis.
The product is 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).
Read also: Lupin gets USFDA nod for generic equivalent of Lyrica Capsules
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