Lupin bags USFDA nod for Ipratropium Bromide Nasal Solution for rhinorrhea
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.
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).
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.
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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