In July 2011, Cumberland filed a response with the U.S. Patent and Trademark Office for its patent application to protect proprietary discoveries related to the new Acetadote formulation. This formulation patent was allowed and issued in China in April 2011 and was recently granted in Australia in October of 2011. The Company has also filed a second U.S. patent application related to the safety profile of the new formulation.
sNDA for Non-Acetaminophen Induced Acute Liver Failure
In the first quarter of 2010, Cumberland submitted an application to the FDA for use of Acetadote in patients with non-acetaminophen acute liver failure. This 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 a transplant and that these patients can also survive a significant number of days longer without transplant. In December 2010, the FDA issued a Complete Response Letter indicating that it had identified additional items that must be addressed prior to any approval.
Cumberland has been in discussions with the FDA to determine a pathway forward for this potential new indication. The Company has identified and is currently analyzing additional patient data to support the application.
In June 2009, the FDA approved Caldolor, the Company's intravenous formulation of ibuprofen, for marketing in the United States. In late 2009, Cumberland launched the product in the U.S. and Caldolor is stocked at wholesalers
|SOURCE Cumberland Pharmaceuticals Inc.|
Copyright©2010 PR Newswire.
All rights reserved