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FDA Issues Complete Response Letter Regarding Acetadote® Supplemental New Drug Application for Acute Liver Failure
Date:12/22/2010

NASHVILLE, Tenn., Dec. 22, 2010 /PRNewswire/ -- Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX) announced today that it has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) regarding its supplemental new drug application (sNDA) for Acetadote® (acetylcysteine) Injection to treat patients with non-acetaminophen induced acute liver failure.

The FDA issues a Complete Response Letter (CRL) when it has completed its review of an application as a formal communication to identify additional work required or items that must be addressed prior to approval of a new product or indication. In its CRL to Cumberland regarding this new indication for Acetadote, the agency confirmed that patients with Coma Grade I/II observed a numerically higher rate of transplant-free survival, but also noted that there was not sufficient evidence of efficacy for the proposed indication of increasing survival in all patients with acute liver failure.

"We appreciate the FDA's efforts to review this application, and we share the agency's commitment to providing pharmaceutical products that meet the highest standards of safety and efficacy for patient groups who will truly benefit," said A.J. Kazimi, Chief Executive Officer of Cumberland Pharmaceuticals. "We continue to believe that the data and literature supporting Acetadote as a treatment for patients suffering from non-acetaminophen acute liver failure are extremely relevant to a critically ill patient population with few treatment alternatives. We plan to request a meeting with the FDA to resolve the outstanding issues related to this application and look forward to working closely with the agency to gain clarity on the pathway to approval for this important indication."

The sNDA for the new indication, filed in March 2010, was based in part on data from a clinical trial led
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SOURCE Cumberland Pharmaceuticals Inc.
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