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( As on 09/06/2022 10:37)

Lupin gets tentative approval for cystic fibrosis drug

The drug major announced that it has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Ivacaftor tablets, 150 mg.

Ivacaftor tablet is a generic equivalent of Kalydeco tablets manufactured by Vertex Pharmaceuticals. These tablets will be manufactured at Lupin's Nagpur facility in India.

Ivacaftor tablets is used to treat certain types of cystic fibrosis, an inborn disease that causes problems with breathing, digestion, and reproduction in adults and children 4 months of age and older.

According to IQVIA, the approved product had an estimated market size of $109 million for the twelve months ending March 2022.

Lupin is a transnational pharmaceutical company. The company develops and commercializes a wide range of branded and generic formulations, biotechnology products and APIs in over 100 markets in the U.S., India, South Africa and across Asia Pacific (APAC), Latin America (LATAM), Europe and Middle-East regions.

The pharma giant reported a consolidated net loss of Rs 518 crore in Q4 FY22 as against a net profit of Rs 460.4 crore in Q4 FY21. Income from operations rose by 2.8% year on year to Rs 3,864.5 crore during the quarter.