USFDA nod to Lupin Ipratropium Bromide Nasal Solution for runny nose
Mumbai: Global pharma major Lupin Limited has announced that it has received 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%, to market a generic equivalent of Atrovent Nasal Spray, 0.06%, of Boehringer Ingelheim Pharmaceuticals, Inc. The product will be manufactured at Lupin’s Pithampur facility in India.
Ipratropium Bromide Nasal Solution (Nasal Spray), 0.06% is indicated for symptomatic relief of rhinorrhea (runny nose) associated with the common cold or seasonal allergic rhinitis for adults and children aged 5 years and older. ]
Ipratropium Bromide Nasal Solution (Nasal Spray), 0.06% (RLD Atrovent) had estimated annual sales of USD 42 million in the U.S. (IQVIA MAT November 2024).
Read also: Lupin Cystic fibrosis drug gets tentative approval from USFDA
Medical Dialogues team had earlier reported the launch of Cyanocobalamin Nasal Spray, 500 mcg/spray (One Spray per Device), after receiving approval from the United States Food and Drug Administration (U.S. FDA).
Read also: Lupin bags tentative USFDA nod for Loteprednol Etabonate Ophthalmic Gel
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. 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.
