Shares of Cumberland Pharmaceuticals Inc. (NASDAQ:CPIX) fell more than 10% on Monday, after a U.S. Food & Drug Administration panel said Friday that it would extend its review of the pharmaceutical company’s drug Acetadote, which is used to treat non-acetaminophen acute liver failure.
The FDA was expected to make a decision based on its review of the drug by September, but that decision will be pushed until December as a result of the agency’s three-month extension of the review.
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"We look forward to continued discussion with the FDA regarding this potentially life-saving treatment for patients who have few alternatives," said A.J. Kazimi, chief executive officer of Cumberland Pharmaceuticals, in a statement Friday.
The drug is currently approved to prevent liver injury after an acetaminophen overdose, a condition which accounts for about half of all liver-failure cases. If approved to treat liver failure that’s not caused by an overdose of acetaminophen, it would be the only approved treatment other than a liver transplant for those patients, according to a release from the company.
Shares of Cumberland Pharmaceuticals fell 61 cents or 10.13% on Monday, closing at $5.41. The stock is down 60%, year-to-date.