Aurobindo Pharma gains FDA approval for Mometasone Furoate Monohydrate Nasal Spray
In a major development within the pharmaceutical industry, Aurobindo Pharma Limited (Aurobindo) announced it has received final approval from the US Food & Drug Administration (USFDA) for the manufacture and market of Mometasone Furoate Monohydrate Nasal Spray, 50 mcg/spray. This approval positions Aurobindo to launch the product in the first quarter of the fiscal year 2025 (Q1FY25), signifying a crucial advancement in the treatment of nasal symptoms associated with seasonal and perennial allergic rhinitis in adults and pediatric patients aged 2 years and older.
The approved nasal spray is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Nasonex Nasal Spray, 50 mcg/spray, of Organon LLC. With an estimated market size of US$ 44.5 million for the twelve months ending January 2024, according to IQVIA data, the product is anticipated to make a significant impact on the market. This approval enhances Aurobindo’s robust portfolio, bringing the total to 507 ANDA approvals (488 Final approvals and 19 tentative approvals) from the USFDA.
Mometasone Furoate Monohydrate Nasal Spray is used to treat cold-like symptoms caused by allergic rhinitis, such as swelling of the inside of the nose due to allergies like hay fever, and for treating nasal polyps. It operates by reducing symptoms of inflammatory conditions and allergic reactions, including redness, swelling, and itching, demonstrating the therapeutic potential of corticosteroids in managing allergic conditions effectively.
Aurobindo Pharma Limited is a globally integrated pharmaceutical company headquartered in Hyderabad, India, with a diverse product range spanning across major therapeutic/product areas. The company’s extensive manufacturing and packaging facilities are approved by leading regulatory agencies worldwide, including the USFDA, UK MHRA, EDQM, Japan PMDA, and others. Aurobindo’s commitment to innovation, quality, and patient care has established it as a leading player in the global pharmaceutical market, continuously working towards improving patient lives worldwide.
This latest approval from the USFDA for Mometasone Furoate Monohydrate Nasal Spray not only marks a significant achievement for Aurobindo Pharma but also signifies the company’s ongoing dedication to addressing the needs of patients with respiratory conditions. As Aurobindo prepares for the product launch in Q1FY25, the pharmaceutical industry and healthcare providers eagerly anticipate the positive impact this will have on managing allergic rhinitis symptoms, reinforcing Aurobindo’s role in advancing global healthcare solutions.