SHREVEPORT, La. (AP) — The Justice Department sued a Louisiana pharmaceutical company Thursday to stop it from making and distributing drugs that the government claims are misbranded and haven’t been approved by regulators.
After inspecting facilities of Sage Pharmaceuticals Inc. in Shreveport in February 2012, the U.S. Food and Drug Administration said it found evidence the company has been making and selling prescription painkillers and over-the-counter cold remedies and wound cleansers without obtaining FDA approval.
The federal lawsuit, filed in Shreveport, says the FDA has repeatedly warned Sage over the past 13 years that it must stop manufacturing and distributing unapproved and misbranded drugs.
The government obtained an injunction against the company in 2000, barring it from making and selling two unapproved drugs. The latest suit seeks a permanent injunction that would halt the company’s drug-making activities until it complies with FDA regulations.
“Today’s action furthers the FDA’s mission of ensuring that all drugs sold to the public are safe and effective, and those companies that undermine this mission will be held accountable,” Justice Department official Stuart Delery said in a statement.
Sage Pharmaceuticals’ president, Jivn Ren Chen, and its director of corporate quality, Charles Thomas, also are named as defendants.
Thomas said he couldn’t comment on the allegations because he hasn’t seen the lawsuit.