CAMBRIDGE, Mass. — The Food and Drug Administration on Monday approved Aegerion Pharmaceuticals' cholesterol drug, Juxtapid.
The drug — an alternative treatment for patients who have a genetic predisposition to high cholesterol — will carry a boxed warning, the strongest level of FDA warning. Juxtapid will be available only through a restricted program due to risk of liver damage.
Aegerion also will conduct a post-approval study to test the long-term safety and efficacy of Juxtapid, the company said. It plans to launch the drug in January.