Drug firm Aurobindo Pharma Ltd on Tuesday (March 19) said the company has received final approval from the US Food & Drug Administration (US FDA) to manufacture and market mometasone furoate monohydrate nasal spray, 50 mcg/spray.
This nasal spray is deemed bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Nasonex nasal spray, 50 mcg/spray, marketed by Organon LLC. The product will be launched in Q1FY25, according to a stock exchange filing.
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 aged two years or older, the company added.
Aurobindo now has a total of 507 ANDA approvals (488 final approvals and 19 tentative approvals) from the US FDA.
Aurobindo Pharma reported a 90.6% year-on-year rise in consolidated net profit to ₹936.2 crore for the October-December quarter of the current financial year. The company reported a profit of ₹491.2 crore in the same period last year. The revenue from operations in Q3FY24 came in at ₹7,351.7 crore, up 14.7% from the year-ago quarter numbers of ₹6,407 crore.
The company's earnings before interest, taxes, depreciation and amortisation (EBITDA) came in at ₹1,601. crore, up from ₹954.4 crore in the year-ago period. The EBITDA margin was at 21.8% against 14.9% in the year-ago period.
Shares of Aurobindo Pharma Ltd ended at ₹990.55, down by ₹26.90, or 2.64%, on the BSE.
(Edited by : Shoma Bhattacharjee)
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