MARLBOROUGH, Mass.--(BUSINESS WIRE)--Sepracor Inc. (Nasdaq: SEPR) today announced that it has submitted an MAA for LUNIVIA® brand eszopiclone to the EMEA for review under the centralized procedure. This procedure provides for a single, coordinated technical review that is conducted by the EMEA on behalf of all EU member states, using experts from national authorities as lead reviewers. Eszopiclone, which is known in the U.S. as LUNESTA®, is indicated in the U.S. for the treatment of insomnia. Approval of the MAA, which is the EU equivalent of a New Drug Application (NDA) that is reviewed by the U.S. Food and Drug Administration 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.
