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ISTA Pharmaceuticals Inc. has lost a bid to stop sales of a generic version of its anti-inflammatory eye drop Xibrom after a judge ruled July 9 the U.S. Food and Drug Administration properly approved the copy sold by Coastal Pharmaceuticals.
U.S. District Judge James Gwin rejected ISTA’s claim that FDA’s approval of the generic copy was arbitrary and capricious because Xibrom’s label wasn’t “currently approved” at the time and therefore couldn’t serve as a reference drug. Gwin re-issued the ruling today to amend the original decision.
ISTA, based in Irvine, California, sued the FDA last year arguing that agency approval of twice-a-day Xibrom, a solution used to reduce pain and inflammation following cataract surgery, had expired once the FDA approved a labeling change for the product.
The case is ISTA Pharmaceuticals v. Food and Drug Administration, 11-cv-0907, U.S. District Court, District of Columbia (Washington).
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