ARTICLE | Company News

FDA extends Acetadote PDUFA date

August 20, 2010 11:32 PM UTC

FDA extended by three months to December the PDUFA date for an sNDA for Acetadote acetylcysteine from Cumberland Pharmaceuticals Inc. (NASDAQ:CPIX) to treat non-acetaminophen acute liver failure. In May, FDA accepted for filing and granted Priority Review to the application, which the company submitted in March. The specific PDUFA date is not disclosed. ...