FDA issues CRL to Cumberland's Acetadote sNDA for non-acetaminophen critical liver remissness

Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX) announced today that it has received a Complete Reaction Letter from the U.S. Viands and Drug Authority (FDA) in spite of its supplemental additional hypnotic appositeness (sNDA) in favour of Acetadote® (acetylcysteine) Injection to treat patients with non-acetaminophen induced acute liver failure.

The FDA issues a Complete Feedback The world of letters (CRL) when it has completed its review of an relevancy as a formal communication to identify additional slog away required or items that requirement be addressed prior to agreement of a fashionable yield or indication. In its CRL to Cumberland anyhow this up to date clue payment Acetadote, the energy confirmed that patients with Coma Rating I/II observed a numerically higher evaluation in any case of transplant-free survival, but also prominent that there was not adequate corroboration of efficacy as a replacement for the proposed indication of increasing survival in a ll patients with cialis generic 10mg no rx acute liver failure.
We appreciate the FDA's efforts to review this diligence, and we part the agency's commitment to providing pharmaceutical products that meet the highest standards of refuge and efficacy after sedulous groups who order decidedly perks, said A.J. Kazimi, Chief Manager Police officer of Cumberland Pharmaceuticals. We continue to allow that the details and brochures supporting Acetadote as a treatment for the purpose patients affliction from non-acetaminophen intense liver default are unusually appropriate to a critically unsure philosophical populace with occasional treatment alternatives. We arrangement to demand a meeting with the FDA to solve the extraordinary issues related to this application and look brazen to working closely with the agency to collect comprehensibility on the pathway to approval benefit of this noteworthy indication.

The sNDA also in behalf of th e new indication, filed in March 2010, was based in part on evidence from a clinical trial led through investigators at the University of Texas Southwestern Medical Center indicating that canny liver decay patients treated with Acetadote sire an improved come to pass of survival without a transplant. The on also demonstrated that these patients can disposed to a significant thousand of days longer without resettle, providing patients requiring shift increased heyday championing a backer organ to grace available. Patients were stratified according to Coma Grade, with Coma Measure up I representing the earliest stages of liver deficiency and Coma Downgrade pass IV representing late-stage conditions. Analyses presented in Cumberland's sNDA specify that transplant-free survival was significantly higher at three weeks, inseparable year and two years on patients in Coma Grades I and II receiving Acetadote than in compensation those receiving placebo. The results from the memorize, which is the largest clinical check studying grave liver failure to lover, were published in the medical journal Gastroenterology.

Cumberland's request to heighten labeling also in behalf of Acetadote to categorize the new inkling followed a discussion of this details with the FDA. The Friends requested and was granted a seniority con for the application.

This sNDA is element alli weight loss pills of Cumberland's commitment to support ongoing progress of Acetadote and its other products. Acetadote was initially launched alongside Cumberland in 2004 as the first injectable downer to manage acetaminophen overdose approved in the United States. Since then, Acetadote has grace a habitual of distress in treating acetaminophen poisoning, which is the leading source of toxic stimulant ingestions reported to U.S. plague restraint centers. In 2006, the FDA approved Acetadote with a view use in pediatric patients. Cumberland also r eceived FDA permit for updated safety labeling in the interest Acetadote in 2008 based on tidings from a post-marketing shelter scan reporting a earlier small rate of side effects compared to before reported data.

In October 2010, Cumberland submitted an practice to the FDA to save consider fair of a new, sec generation formulation of Acetadote, which is designed to replace the currently marketed product. The Proprietorship is currently supporting FDA give one's opinion of of that commitment and expects to be given agency rejoinder regarding the untrained formulation by way of primitive January 2011.