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 Mumbaibased drug maker said. As per IQVIA MAT March 2022 data, Ivacaftor tablets had
estimated annual sales of USD 109 million in the US.
