Pacira Pharmaceuticals Inc. said Thursday that it received a warning letter from regulators about marketing for an injectable drug that numbs post-surgical pain that the letter says is misleading.
Shares of Pacira fell nearly 6% in premarket trading.
In the letter, the U.S. Food and Drug Administration said Pacira promotes its drug Exparel as being able to work for up to 72 hours when it has only been approved for 24-hour pain relief.
“These claims overstate Exparel’s efficacy and are misleading,” the FDA said in the letter.
Pacira, based in Parsippany, New Jersey, said it takes regulatory compliance very seriously.
“We plan to explain our position to the FDA and will provide an update upon resolution of these issues,” the company said in a statement.
In trading before the stock market opened, Pacira shares fell $6.28, or 5.9%, to $100.
Date: September 25, 2014
Source: Associated Press
Filed Under: Drug Discovery