Sepracor submits LUNIVIA (Lunesta) marketing authorization application for Europe

Co announces that it has submitted an M.A.A. for LUNIVIA brand eszopiclone to the E.M.E.A. for review under the centralized procedure. This procedure provides for a single, coordinated technical review that is conducted by the E.M.E.A. on behalf of all E.U. member states, using experts from national authorities as lead reviewers. Approval of the M.A.A., which is the E..U equivalent of a New Drug Application that is reviewed by the FDA to determine if a pharmaceutical product should be approved for marketing in the U.S., would allow authorization to market LUNIVIA in as many as 27 EU member countries.