Aurobindo Pharma bags USFDA nod for Mometasone Furoate Monohydrate Nasal Spray
Mometasone Furoate Monohydrate Nasal Spray, 50 mcg/spray, is indicated for the treatment of the nasal symptoms of seasonal allergic and perennial allergic rhinitis, in adults and paediatric patients 2 years of age and older.
Hyderabad: Aurobindo Pharma Limited has announced that the Company has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Mometasone Furoate Monohydrate Nasal Spray, 50 mcg/spray.
The product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Nasonex Nasal Spray, 50 mcg/spray of Organon LLC.
Mometasone Furoate Monohydrate Nasal Spray, 50 mcg/spray, is indicated for the treatment of the nasal symptoms of seasonal allergic and perennial allergic rhinitis, in adults and paediatric patients 2 years of age and older.
Seasonal allergic rhinitis, known as hay fever, arises from allergens like pollen, causing sneezing, congestion, and itchy eyes during specific seasons. Perennial allergic rhinitis, persistent year-round, is triggered by indoor allergens such as dust mites and pet dander, leading to similar symptoms. Proper management involves medication, allergen avoidance, and sometimes immunotherapy.
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The product will be launched in Q1FY25.
The approved product has an estimated market size of US$ 44.5 million for the twelve months ending January 2024, according to IQVIA. Aurobindo now has a total of 507 ANDA approvals (488 Final approvals and 19 tentative approvals) from USFDA.
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Aurobindo Pharma Limited is an integrated global pharmaceutical company headquartered in Hyderabad, India. The Company develops, manufactures, and commercializes a wide range of generic pharmaceuticals, branded specialty pharmaceuticals and active pharmaceutical ingredients globally in over 150 countries. The company has 25 manufacturing and packaging facilities that are approved by leading regulatory agencies including USFDA, UK MHRA, EDQM, Japan PMDA, WHO, Health Canada, South Africa MCC, Brazil ANVISA. The company’s product portfolio is spread over 7 major therapeutic/product areas encompassing CNS, AntiRetroviral, CVS, Antibiotics, Gastroenterological, Anti-Diabetics and Anti-Allergic, supported by a strong R&D set-up.
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