Lupin Secures FDA Approval For Generic Atrovent® Nasal Spray
Lupin receives FDA approval for Ipratropium Bromide Nasal Spray 0.06%, a generic alternative to Atrovent® Nasal Spray.
Breaking News
Jan 29, 2025
Simantini Singh Deo
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Lupin Limited announced today that the United States Food and Drug Administration (U.S. FDA) has approved its Abbreviated New Drug Application (ANDA) for Ipratropium Bromide Nasal Solution (Nasal Spray) 0.06% to produce a generic equivalent of Boehringer Ingelheim Pharmaceuticals Inc.'s Atrovent® Nasal Spray 0.06%. Lupin will make this product using facilities located in Pithampur, India.
The nasal spray formulation of Ipratropium Bromide Nasal Solution 0.06% offers symptom relief for rhinorrhea in typical cold patients and those with seasonal allergic rhinitis for patients older than 5 years. IQVIA MAT November 2024 data indicates total U.S. sales reached USD 42 million annually for Ipratropium Bromide Nasal Solution (Nasal Spray) 0.06% (RLD Atrovent®).