Cumberland Pharmaceuticals, Inc. (CPIX)

[BioRunUp]

CPIX- Priority Review PDUFA Date of 9/10/10 for Acetadote

The PDUFA date reported at BioRunUp on Tuesday has now been officially confirmed in Cumberlands latest 8-K filing with the SEC from 7/21/10

( See link )
http://investor.shareholder.com/cpix...299933-10-2760

CPIX- Priority Review PDUFA Date of 9/10/10 for Acetadote
http://www.biorunup.com/1102/cpix-pdufa-91010/

Highlights

In March 2010, we submitted a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) for the use of Acetadote in patients with non-acetaminophen acute liver failure. The sNDA includes data from a clinical trial led by investigators at the University of Texas Southwestern Medical Center indicating that acute liver failure patients treated with Acetadote have a significantly improved chance of survival without a transplant. These patients can also survive a significant number of days longer without transplant, providing patients requiring transplant increased time for a donor organ to become available.

Acute liver failure is associated with a high mortality rate and frequent need for liver transplantation. Approximately half of acute liver failure cases are caused by acetaminophen poisoning while the other half result from a variety of causes including hepatitis and alcohol. Currently, transplantation of the liver is the only treatment for patients with liver failure not caused by acetaminophen overdose.

In May 2010, the FDA officially accepted the sNDA and granted a priority review, with a Prescription Drug User Fee Act date of September 10, 2010. In addition to expanded labeling for Acetadote, we have requested additional exclusivity for the product. If approved, we expect to begin marketing Acetadote with the new indication in 2011.