Lupin receives tentative approval from USFDA to market Ivacaftor tablets

The product is the generic equivalent of Vertex Pharmaceuticals' Kalydeco tablets, Lupin said in a statement

Lupin, USFDA, US Food and Drug Administration, Vertex Pharmaceuticals, Ivacaftor tablets

Drug maker Lupin on Wednesday said it has received tentative approval from the US health regulator to market Ivacaftor tablets, used to treat cystic fibrosis, in America.

The company has received tentative approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Ivacaftor tablets, 150 mg strength, Lupin said in a statement.

The product is the generic equivalent of Vertex Pharmaceuticals' Kalydeco tablets, it added. The product will be manufactured at the company's Nagpur facility, the Mumbai-based drug maker said.

As per IQVIA MAT March 2022 data, Ivacaftor tablets had estimated annual sales of USD 109 million in the US. The product will be manufactured at the company's Nagpur facility, the Mumbai-based drug maker said.