Lupin Secures US FDA Nod for Ipratropium Bromide Nasal Solution ANDA

Global pharmaceutical giant Lupin Limited has revealed that it has gained approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA) for Ipratropium Bromide Nasal Solution (Nasal Spray), 0.06%, enabling it to market a generic version of Atrovent Nasal Spray, 0.06%, from Boehringer Ingelheim Pharmaceuticals, Inc. The product will be produced at Lupin’s Pithampur facility in India.

Ipratropium Bromide Nasal Solution (Nasal Spray), 0.06%, is recommended for alleviating symptoms of rhinorrhea (runny nose) linked to the common cold or seasonal allergic rhinitis in individuals aged 5 and older.

Ipratropium Bromide Nasal Solution (Nasal Spray), 0.06% (RLD Atrovent) was projected to have yearly sales of USD 42 million in the U.S. (IQVIA MAT November 2024). The Medical Dialogues team previously announced the introduction of Cyanocobalamin Nasal Spray, 500 mcg/spray (One Spray per Device), following approval from the United States Food and Drug Administration (U.S. FDA).

Lupin Limited is a worldwide pharmaceutical leader based in Mumbai, India, with its products available in more than 100 markets. Lupin focuses on pharmaceutical items, such as branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. The company holds a robust presence in India and the U.S. in various therapy domains, such as respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women's health. Lupin operates 15 advanced manufacturing facilities and 7 research centers worldwide.