Aurobindo Pharma has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Mometasone Furoate Monohydrate Nasal Spray, 50 mcg/spray, which is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Nasonex Nasal Spray, 50 mcg/spray of Organon LLC. The product will be launched in Q1FY25.
The approved product has an estimated market size of $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.
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.
Aurobindo Pharma is engaged in manufacturing pharmaceutical products. It offers active pharmaceutical ingredients, intermediates and generic formulations like astemizole, domeperidone and omeprazole; anti-infective, oral and sterile antibiotics, pain management and osteoporosis segments.
