NASHVILLE, Tenn. (AP) – Cumberland Pharmaceuticals Inc. said the Food and Drug Administration rejected the company’s request to expand approval for the liver failure drug Acetadote.
The drug is already approved to treat liver failure caused by an overdose of the painkiller ingredient acetaminophen. The company was asking for expanded approval as a treatment for liver failure caused by factors other than an overdose of acetaminophen.
The agency said that studies had not proved the drug was effective enough for the additional use. The company disagrees and plans to meet with the agency to discuss its options.
Date: December 22, 2010
Source: Associated Press
Filed Under: Drug Discovery