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BromSite Approval History

FDA Approved: Yes (First approved April 8, 2016)
Brand name: BromSite
Generic name: bromfenac
Dosage form: Ophthalmic Solution
Company: Sun Pharmaceutical Industries Inc.
Treatment for: Postoperative Ocular Inflammation

BromSite (bromfenac) is a low dose nonsteroidal anti-inflammatory drug (NSAID) ophthalmic solution for the treatment of inflammation and prevention of pain in patients undergoing cataract surgery.

Development History and FDA Approval Process for BromSite

DateArticle
Apr  9, 2016Approval Sun Pharma Receives FDA Approval For BromSite (bromfenac ophthalmic solution)
Aug 17, 2015InSite Vision Announces FDA Acceptance of NDA Filing for BromSite (0.075% bromfenac)
Jun 11, 2015InSite Vision Announces Completion of the NDA Submission for BromSite

Further information

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