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FDAnews Drug Daily Bulletin
July 26, 2012 | Vol. 9 No. 146
Courts Rule on, Asked to Intervene on Brand’s Generic-Evading Tactics
An Ohio District Court ruling that the FDA can approve generics on a withdrawn brand product could spell bad news for brand drugmakers trying to ward off generic competition. After generic-drug makers Coastal Pharmaceuticals and Mylan filed ANDAs referencing the twice-daily eye drug Xibrom (bromfenac), ISTA Pharmaceuticals petitioned the FDA arguing a generic couldn’t be approved unless its labeling mirrored that of the recently approved, once-daily Bromday (bromfenac), which ISTA still carried exclusivity on.
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