Lupin bags Tentative Approval from USFDA for Ivacaftor Tablets

8 Jun 2022 , 01:00 PM

Global pharma major Lupin Limited has announced that the company has received tentative approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) Ivacaftor Tablets, 150 mg.

The approval received is to market a generic equivalent of Kalydeco Tablets, 150 mg of Vertex Pharmaceuticals Incorporated.

The company will manufacture the product at its Nagpur facility in India. As per IQVIA MAT March 2022, Ivacaftor Tablets (RLD: Kalydeco Tablets) have an estimated annual sale of US $109 million in the U.S.

Lupin stands as the third-largest pharmaceutical company in the U.S. by prescriptions. During FY22, the company invested 8.7% of its revenue in research and development.

Lupin runs 15 manufacturing sites, 7 research centres, and more than 20,000 talent heads working globally. It has been consistently recognized as a ‘Great Place to Work’ in the Biotechnology & Pharmaceuticals sector.

At around 1.02 PM, Lupin was trading at Rs613.55 up by Rs3.65 or 0.6% from its previous closing of Rs609.90 on the BSE. The scrip touched intraday high and low of Rs614.60 and Rs603 respectively.