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Lupin gets nod from USFDA for Ipratropium Bromide Nasal Solution
Feb-10-2025

Lupin has received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Ipratropium Bromide Nasal Solution (Nasal Spray), 0.03% (21 mcg/spray), to market a generic equivalent of Atrovent Nasal Spray, 0.03%, of Boehringer Ingelheim Pharmaceuticals, Inc. The product will be manufactured at Lupin’s Pithampur facility in India.

Ipratropium Bromide Nasal Solution (Nasal Spray), 0.03% is indicated for the symptomatic relief of rhinorrhea associated with allergic and nonallergic perennial rhinitis in adults and children aged 6 years and older. Ipratropium Bromide Nasal Solution (Nasal Spray), 0.03% (RLD Atrovent) had estimated annual sales of $22 million in the U.S. (IQVIA MAT December 2024). 

Lupin is an innovation led transnational pharmaceutical company producing, developing and marketing a wide range of branded and generic formulations, biotechnology products and active pharmaceutical ingredients (APIs) globally.

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