Lupin bags USFDA nod for cystic fibrosis drug Ivacaftor
This product will be manufactured at Lupin’s Nagpur facility in India.
Mumbai: Global pharma major, Lupin Limited, today announced that the company has received tentative approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Ivacaftor Tablets, 150 mg used to treat cystic fibrosis.
The product is a generic equivalent of Kalydeco Tablets, 150 mg of Vertex Pharmaceuticals Incorporated.
This product will be manufactured at Lupin's Nagpur facility in India.
Ivacaftor Tablets (RLD: Kalydeco Tablets) had estimated annual sales of USD 109 million in the U.S. (IQVIA MAT March 2022).
Read also: Lupin gets USFDA nod for generic equivalent of Lyrica Capsules
Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. 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 Company specializes in the cardiovascular, anti-diabetic, and respiratory segments and has significant presence in the anti-infective, gastro-intestinal (GI), central nervous system (CNS) and women's health areas.
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