NEW DELHI: Lupin, India's largest pharmaceutical company, announced on Wednesday that it has received tentative approval from the US Food and Drug Administration to market Ivacaftor pills, which are used to treat cystic fibrosis.
The US Food and Drug Administration (USFDA) has tentatively approved Lupin's abbreviated new drug application (ANDA) for Ivacaftor tablets, 150 mg strength, the company said in a statement.
The medicine is a generic version of Vertex Pharmaceuticals' Kalydeco pills, according to the company.
The product will be made at the company's Nagpur facility, according to the Mumbai-based pharmaceutical company. Ivacaftor tablets have expected annual sales of USD 109 million in the United States, according to IQVIA MAT data from March 2022.
Lupin Limited, based in Mumbai, Maharashtra, India, is an Indian multinational pharmaceutical corporation. It is one of the world's most profitable generic pharmaceutical companies. Paediatrics, cardiovascular, anti-infectives, diabetology, asthma, and anti-tuberculosis are among the company's primary emphasis areas.
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