NASHVILLE, Tenn. (AP) -- Cumberland Pharmaceuticals Inc. said Wednesday 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.
Shares of Cumberland fell 90 cents, or 13 percent, to $6 in premarket trading. The stock closed at $6.90 during the regular trading session on Tuesday.
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.
Shares of Cumberland fell 90 cents, or 13 percent, to $6 in premarket trading. The stock closed at $6.90 during the regular trading session on Tuesday.
