Lupin gets nod from USFDA for Ipratropium Bromide Nasal Solution

10 Feb 2025 Evaluate

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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