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FDA Approves Simplified Dosing for Cumberland’s Acetadote

The newly approved dosing regimen combines the first two bags of the standard regimen into a single, slower infusion.

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By: Charlie Sternberg

Associate Editor

The FDA has approved a supplemental New Drug Application (sNDA) for Cumberland Pharmaceuticals Inc.’s Acetadote (N-acetylcysteine for injection) product, an intravenous (IV) formulation of N-acetylcysteine (NAC) indicated to prevent or lessen liver injury after ingestion of potentially toxic quantities of acetaminophen.   Acetaminophen, a common over-the-counter pain reliever and fever reducer, is the leading cause of acute liver failure in the United States. Each year, thousands of individual...

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