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Ista submits NDA for topical antiinflammatory drug

Ista Pharmaceuticals has submitted a new drug application to the FDA for Xibrom one daily, as a treatment for inflammation, pain, and photophobia following cataract surgery.

Xibrom is a topical non-steroidal anti-inflammatory compound for the treatment of ocular inflammation and pain. Xibrom, approved in 2005, is the first and only FDA-approved twice-daily NSAID for inflammation and reduction of pain following cataract surgery.

Xibrom, under a different trade name but identical formulation, was launched in Japan in 2000 by Senju Pharmaceuticals. Ista acquired US marketing rights for Xibrom in 2002 and launched the product in the US in 2005.