FDA Cleared Of Wrongdoing In Generic Xibrom Suit

Law360, New York (July 9, 2012, 7:50 PM EDT) -- A Washington federal judge said Monday that the U.S. Food and Drug Administration had not improperly approved a generic version of Ista Pharmaceuticals Inc.'s post-cataract surgery eye drop medication, Xibrom.

U.S. District Judge James S. Gwin granted the FDA's motion for summary judgment against ISTA, ruling against the pharmaceutical makers' claims that the government had violated the law when it approved an abbreviated new drug application filed by Metrics Inc., which does business as Coastal Pharmaceuticals.

“The court concludes that the FDA did not act unlawfully...
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