ARTICLE | Clinical News

Acetadote acetylcysteine regulatory update

November 22, 2010 8:00 AM UTC

Cumberland disclosed in its 3Q10 earnings that FDA accepted for filing and granted Priority Review to an sNDA from Cumberland for a next generation Acetadote acetylcysteine to treat acetaminophen overdose. The company expects an FDA response by early January. Cumberland said the next generation product would replace the current product, and was requested as part of FDA's 2004 approval of Acetadote as a post-marketing commitment. ...