The Food and drug Administration (FDA) of US has postpones its review of Acetadote as a treatment for patients with non-acetaminophen acute liver failure, said Cumberland Pharmaceuticals Inc.
The new date for the review has been set in December this year following an extension of three more months.
Acetadote is an injectable drug which has already been approved for the treatment of acetaminophen poisoning. Following this news the shares of Cumberland Pharmaceuticals rose by 19 cents or 3.3 percent to close at $6.02.
A. J. Kazimi, Chief Executive Officer of Cumberland Pharmaceuticals said, "We look forward to continued discussion with the FDA regarding this potentially life-saving treatment for patients who have few alternatives."
The company stated that it had launched Acetadote in 2004 as the first US-approved injectable drug to treat acetaminophen overdose and in 2006 it received the approval from FDA to use Acetadote in pediatric patients.
FDA also granted approval to the company for updates labeling regarding the safety of Acetadote in 2008 based on new information from a post-marketing safety study which reported a lower-incidence of side-effects in comparison to previously reported data.
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