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FDA to review new drug application for BromSite

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The FDA has accepted for review a new drug application for BromSite, according to a press release from InSite Vision.

The FDA assigned a Prescription Drug User Fee Act action date of April 10, 2016.

InSite is seeking marketing approval for BromSite, a low-dose 0.075% bromfenac ophthalmic solution, as an agent for treating inflammation and preventing pain after cataract surgery.

 “The FDA’s notification letter is an important milestone for the BromSite NDA and, importantly, satisfies a condition of our merger agreement with QLT Inc.,” InSite Vision Chief Executive Officer Timothy Ruane said in the release.

In June, InSite and QLT announced an agreement to merge. A condition of the merger was that the FDA identify no filing review issues within 74 days of receiving the NDA that would likely require further clinical studies of BromSite before marketing in the U.S.