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Cumberland Pharmaceuticals Reports First Quarter 2011 Financial Results
Date:5/4/2011

compromising potency, solubility or stability. In January 2011, the FDA approved the new formulation, which does not contain Ethylene diamine tetracetic acid or any other stabilization or chelating agents and is free of preservatives. Cumberland completed the U.S. launch of the next generation product during the first quarter of 2011, and no longer manufactures the original formulation. The Company is also prosecuting a patent application with the U.S. Patent and Trademark Office to protect the proprietary new formulation.

Supplemental New Drug Application for Acetadote

In March 2010, Cumberland submitted an application to the FDA for the use of Acetadote in patients with non-acetaminophen acute liver failure. The sNDA included data from a clinical trial led by investigators at the University of Texas Southwestern Medical Center indicating that early-stage acute liver failure patients treated with Acetadote have a significantly improved chance of survival without transplant, and that these patients can survive a significant number of days longer without transplant. In December 2010, the FDA issued a Complete Response Letter indicating that it had completed its review of the application and had identified additional items to be addressed prior to approval of the potential new indication. Cumberland has initiated discussions with FDA to gain clarity on and determine whether it can address the additional requirements for approval.

Other Highlights

In January 2011, Joey Jacobs joined Cumberland's Board of Directors. He is the former Chairman, President and Chief Executive Officer of Psychiatric Solutions, which he co-founded in 1997 and grew into a $2 billion healthcare provider. Mr. Jacobs has more than 30 years of experience in the healthcare industry, including 21 years at Hospital Corporation of America (HCA).  The Company believes his hospital expertise and experience building a public healthcare company make him a valuable
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SOURCE Cumberland Pharmaceuticals Inc.
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