Drug news

InSite Vision files NDA for BromSite (0.075% bromfenac) treatment of inflammation and prevention of ocular pain following post-cataract surgery

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Last updated:31st Aug 2015

Published:31st Aug 2015

Source: Pharmawand

InSite Vision Inc, a company developing ophthalmic products for unmet eye care needs, announced that the FDA has accepted for review InSite’s New Drug Application (NDA) for BromSite (0.075% bromfenac). The FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of April 10, 2016. InSite is seeking FDA approval for BromSite in the treatment of inflammation and prevention of ocular pain in the post-cataract surgery setting.

Comment: InSite Vision is party to a merger agreement with QLT Inc.

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