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Aurobindo Pharma bags USFDA nod for Mometasone Furoate Monohydrate Nasal Spray
![Aurobindo Pharma bags USFDA nod for Mometasone Furoate Monohydrate Nasal Spray Aurobindo Pharma bags USFDA nod for Mometasone Furoate Monohydrate Nasal Spray](https://medicaldialogues.in/h-upload/2024/01/19/750x450_230521-usfda-50.webp)
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.
Read also: Aurobindo Pharma bags USFDA okay for Duchenne muscular dystrophy drug Deflazacort
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.
Read also: Aurobindo Pharma arm announces successful Phase 1 clinical study outcome of their BP11 product
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.
Read also: Aurobindo Pharma bags USFDA nod for Fingolimod Capsules for multiple sclerosis
Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751
Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: editorial@medicaldialogues.in. Contact no. 011-43720751