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Cumberland Pharmaceuticals Inc.

Acetadote Supplemental New Drug Application for Acute Liver Failure Submitted to FDA

Published in Medical Letter on the CDC and FDA, April 18th, 2010

Cumberland Pharmaceuticals Inc. (NASDAQ:CPIX) has submitted a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) for the use of Acetadote® (acetylcysteine) Injection in patients with non-acetaminophen acute liver failure. Acetadote was launched by Cumberland in 2004 as the first U.S.-approved injectable drug to treat acetaminophen overdose.

The sNDA includes data from a clinical trial led by investigators at the University of Texas Southwestern Medical Center indicating that acute liver failure patients treated with Acetadote have a significantly improved chance of survival without a transplant. These patients can also survive a...

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