FDA Defends Approval Of Generic Acetaminophen OD Drug

Law360, New York (January 18, 2013, 5:18 PM EST) -- The U.S. Food and Drug Administration on Friday urged a Washington federal judge to nix Cumberland Pharmaceuticals Inc.’s bid to block a generic version of its acetaminophen-overdose treatment after it changed the formula over safety concerns, saying Cumberland’s suit would unfairly extend its monopoly on the drug.

Cumberland sued the FDA in November, claiming the agency approved InnoPharma Inc.'s generic version of Acetadote containing edetate disodium, or EDTA, after directing Cumberland to evaluate the feasibility of removing EDTA from the drug due to potential safety concerns...
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