Cumberland Pharmaceuticals Inc. (CPIX) announced that the review of the supplemental new drug application or sNDA for the use of Acetadote Injection in patients with non-acetaminophen acute liver failure has been extended by the U.S. Food and Drug Administration or FDA.
The company stated that the review has been extended by three months resulting in a new Prescription Drug User Fee Act or PDUFA goal date in December 2010.
Cumberland commented that it had launched Acetadote in 2004 as the first U.S.-approved injectable drug to treat acetaminophen overdose and in 2006, got FDA approval to use Acetadote in pediatric patients.
The company also received FDA approval for updated labeling regarding the safety of Acetadote in 2008 based on new information from a post-marketing safety study reporting a lower-incidence of side effects compared to previously reported data.
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