Acute Liver Failure
Cumberland Pharmaceuticals Announces Extension of FDA Review of Acetadote(R) Supplemental New Drug Application
Published in Hepatitis Weekly, September 6th, 2010
Cumberland Pharmaceuticals Inc. (NASDAQ:CPIX) announced the U.S. Food and Drug Administration (FDA) has extended its review of the supplemental new drug application (sNDA) for the use of Acetadote® (acetylcysteine) Injection in patients with non-acetaminophen acute liver failure. The review has been extended by three months resulting in a new Prescription Drug User Fee Act (PDUFA) goal date in December 2010.
"We look forward to continued discussion with the FDA regarding this potentially life-saving treatment for patients who have few alternatives," said A.J. Kazimi, Chief Executive Officer of Cumberland Pharmaceuticals.
Acute liver failure is a...
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Source: Hepatitis Weekly (2010-09-06)
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