FDA Urged To Block Unapproved Post-Surgery Injections

Law360, New York (September 4, 2013, 7:22 PM EDT) -- The U.S. Food and Drug Administration must swiftly block sales of an unapproved injectable drug sold by Fresenius Kabi AG, Cardinal Health Inc. and other companies because the post-surgery product is less safe than a recently approved version, according to a citizen petition released Wednesday.

The petition from Missouri-based Eclat Pharmaceuticals LLC, a unit of France-based Flamel Technologies SA, says its Bloxiverz drug is the only injectable neostigmine product with FDA approval. Neostigmine is administered after surgery to reverse the effects of so-called non-depolarizing neuromuscular blocking...
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