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 $109 million in the US.