Acusphere Inc. Announces Submission of Marketing Authorisation Application for Imagify in Europe and Start of Procedural Review
Published: Oct 24, 2012
LEXINGTON, Mass.--(BUSINESS WIRE)--Acusphere, Inc. (ACUSD.PK) today announced that it has submitted the Marketing Authorisation Application (MAA) for its lead product candidate, Imagify™ (Perflubutane Polymer Microspheres) lyophilisate for dispersion for injection with the European Medicines Agency (EMA) to support the regulatory review of Imagify in the European Union (EU). The MAA is being submitted via the centralized procedure that would enable simultaneous approval in all EU countries. The validation process for the MAA has been successfully completed, and the substantive review process is now underway by the Committee for Medicinal Products for Human Use (CHMP). The CHMP opinion is expected in Q4 2013.