New Delhi, Apr 10: Drug major Sun Pharmaceutical Industries has received approval from the US health regulator for its non-steroid drug BromSite used to treat inflammation and prevent pain in patients undergoing cataract surgery.
One of the company’s wholly-owned subsidiaries “has received approval from USFDA for its New Drug Application (NDA) related to BromSite (bromfenac ophthalmic solution) 0.075 per cent for the treatment of postoperative inflammation and prevention of ocular pain in patients undergoing cataract surgery,” Sun Pharmaceutical Industries said in a filing to BSE.
The drug has been developed by InSite Vision which the company had acquired in November 2015, it added.
The company is likely to commercialise BromSite through its newly formed US-based division Sun Ophthalmics in the second half of 2016, it said.
“As per IMS MAT January 2016, the US NSAID ophthalmic market grew by 8 per cent, generating approximately USD 400 million in sales and about 4 million prescriptions, providing an attractive market for Sun Pharma to participate,” it added.
Minnesota Eye Consultants MD and Adjunct Professor Emeritus at the University of Minnesota, Department of Ophthalmology, Richard L. Lindstrom said, “Over the years, I have worked closely with the InSite team and watched them develop multiple high quality products using the DuraSite platform.”
“I am confident there will be significant clinician interest in this new product,” he added.
As per the USFDA, NDA application is the vehicle through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the US.
Sun Pharma is the world’s fifth largest specialty generic pharmaceutical company and India’s largest drug maker.