Lupin bags USFDA nod for Ipratropium Bromide Nasal Solution for rhinorrhea
Written By : Ruchika Sharma
Medically Reviewed By : Dr. Kamal Kant Kohli
Published On 2025-02-11 05:00 GMT | Update On 2025-02-11 05:00 GMT
Mumbai: Global pharma major Lupin Limited has announced that it 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 BoehringerIngelheim 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 USD 22 million in the U.S. (IQVIA MAT December 2024).
Medical Dialogues team had earlier reported that it has received USFDA approval for its ANDA for Ipratropium Bromide Nasal Solution, 0.06%.
Lupin Limited is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets. Lupin specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. Trusted by healthcare professionals and consumers globally, the company has a strong position in India and the U.S. across multiple therapy areas, including respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women's health. Lupin has 15 state-of-the-art manufacturing sites and 7 research centers globally.
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