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Cumberland (CPIX) Updated Labeling for Acetadote Injection Approved by FDA

June 10, 2013 8:07 AM EDT
Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX) announced today that the U.S. Food and Drug Administration (FDA) has approved updated labeling for Acetadote (acetylcysteine) Injection. The new labeling revises the product's indication and offers new dosing guidance for specific patient populations. Acetadote is free of EDTA or any other stabilization or chelating agents.

Furthermore, specific dosing guidance is now included for patients weighing over 100 kg. New language has also been added to alert health care providers that in certain clinical situations, therapy should be extended for some patients.


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