Aegerion Pharmaceuticals Inc said the U.S. health regulator approved its drug as an alternative treatment for patients who have a genetic predisposition to high cholesterol.
The drug, Juxtapid, would carry a boxed warning -- the strongest label warning -- and will be available only through a restricted program due to risk of liver damage.
Shares of the company fell nearly 4 percent to $24.76 in early trade on the Nasdaq on Monday.
Aegerion will also conduct a post-approval study to test the long-term safety and efficacy of Juxtapid, the company said on a conference call. It plans to launch the drug in January.
Juxtapid, Aegerion's first approved product, was backed by an advisory panel of independent experts on October 17. The panel looks at a drug's approval application and advises the FDA on whether it should be approved.
The panel also recommended a drug from Sanofi SA and Isis Pharmaceutical Inc, Kynamro, to treat the same disorder on Oct 18.
Aegerion's shares were down 2 percent at $25.15 in morning trade. The stock has gained about 23 percent since the FDA panel's report to Friday's close.
(Reporting By Pallavi Ail in Bangalore; Editing by Sriraj Kalluvila)