News | News By Subject | News by Disease News By Date | Search News
Get Our FREE
Industry eNewsletter
email:    
   

Acusphere Inc. (ACUS) Announces Submission of Marketing Authorisation Application for Imagify™ in Europe and Start of Procedural Review



10/24/2012 9:26:56 AM

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.

Read at BioSpace.com


comments powered by Disqus
   

ADD TO DEL.ICIO.US    ADD TO DIGG    ADD TO FURL    ADD TO STUMBLEUPON    ADD TO TECHNORATI FAVORITES