Sun Pharmaceutical Industries, the world's fifth largest specialty generic pharmaceutical company and India's largest drug maker, received an approval from the US health regulator USFDA for its non-steroid drug BromSite, which is used to treat inflammation and prevent pain in patients undergoing cataract surgery.
In a BSE filling today, Sun Pharmaceutical Industries stated that its wholly-owned subsidiaries have received approval from the USFDA for its New Drug Application (NDA) related to BromSite for the treatment of postoperative inflammation and prevention of ocular pain in patients undergoing cataract surgery.
The drug has been developed by InSite Vision, which the company had acquired in November 2015, it added.
The company is likely to commercialize BromSite through its newly-formed US-based division Sun Ophthalmics in the second half of 2016, it said.
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.