Drugmaker Lupin said on Wednesday it had received preliminary approval from US health regulators to sell Ivacaftor tablets for cystic fibrosis in the US.

In a statement, Lupin said the company had received preliminary approval from the USFDA for an abbreviated new drug application (ANDA) for Ivacaftor tablet, 150 mg strength.

The product is a generic version of Vertex Pharmaceuticals’ Kalydeco tablets. The Mumbai-based drugmaker said the product would be manufactured at the company’s Nagpur facility.

Annual US sales of Ivacaftor tablets are estimated at $109 million, according to IQVIA MAT data for March 2022. The Mumbai-based drugmaker said the product would be manufactured at the company’s Nagpur facility.