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FDAnews Drug Daily Bulletin
Nov. 20, 2012 | Vol. 9 No. 228
Cumberland Suit States FDA Wrongfully Approved Generic of Its Overdose Drug Acetadote
Cumberland Pharmaceuticals is taking the FDA to court, alleging the agency violated federal law when it approved InnoPharma’s generic version of acetaminophen-poisoning treatment Acetadote. Cumberland removed the drug from the market for safety reasons, it argues. In approving InnoPharma’s version, the FDA violated federal law and regulations and treated two similarly situated parties differently, Cumberland attests in a Nov. 13 suit filed in the U.S. District Court for the District of Columbia.
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