Press Release
Hyderabad, India, March 19, 2024
Aurobindo Pharma receives USFDA Approval for Mometasone Furoate Monohydrate Nasal Spray
50 mcg/spray
Aurobindo Pharma Limited is pleased to announce that it 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 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.
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.
About Aurobindo Pharma Limited
Aurobindo Pharma Limited (www.aurobindo.com), (NSE: AUROPHARMA, BSE: 524804, Reuters: ARBN.NS,
Bloomberg: ARBP IN) 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 robust product portfolio is spread over 7 major therapeutic/product areas encompassing CNS, Anti- Retroviral, CVS, Antibiotics, Gastroenterological, Anti-Diabetics and Anti-Allergic, supported by a strong R&D set-up.
To know more, please log on to www.aurobindo.com | |
For further information or queries, please contact: | |
Shriniwas P. Dange | Kavita Jayaram |
Investor Relations | Corporate Communications |
Phone: +91 40 66721551 / 66725000 | Phone: +91 40 66725005 / 66725000 |
Email: ir@aurobindo.com | Email: kavita.jayaram@aurobindo.com |
Corp. Off.: Galaxy, Floors: 22-24, Plot No.1, Survey No.83/1, Hyderabad Knowledge City, Raidurg Panmaktha, Ranga Reddy District, Hyderabad - 500 032, Telangana, India. Tel : +91 40 6672 5000 / 6672 1200 Fax: +91 40 6707 4044.
Regd. off.: PlotNo. 2, Maithrivihar, Ameerpet, Hyderabad - 500038 T.S., INDIATel:+91 40 23736370/ 23747340 Fax:+914023741080 / 2374 6833
Disclaimer:
This press release contains statements that may constitute "forward looking statements" including and without limitation, statements relating to product characteristics and uses, sales potential and target dates for product launch, implementation of strategic initiatives, and other statements relating to our future business developments and economic performance. While these forward-looking statements represent our judgment and future expectations concerning the development of our business, a number of risks, uncertainties and other factors could cause actual developments and results to differ materially from our expectations. The company undertakes no obligation to publicly revise any forward-looking statements to reflect future events or circumstances and will not be held liable for any use of this information.
Corp. Off.: Galaxy, Floors: 22-24, Plot No.1, Survey No.83/1, Hyderabad Knowledge City, Raidurg Panmaktha, Ranga Reddy District, Hyderabad - 500 032, Telangana, India. Tel : +91 40 6672 5000 / 6672 1200 Fax: +91 40 6707 4044.
Regd. off.: PlotNo. 2, Maithrivihar, Ameerpet, Hyderabad - 500038 T.S., INDIATel:+91 40 23736370/ 23747340 Fax:+914023741080 / 2374 6833