Acusphere Inc. (ACUS) Withdraws Its European Marketing Authorization Application For Imagify
8/28/2014 10:31:29 AM
LEXINGTON, Mass.--(BUSINESS WIRE)--Acusphere, Inc. (ACUSD.PK) announced today the strategic decision to voluntarily withdraw its Marketing Authorization Application (MAA) submitted to the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for Imagify™ (Perflubutane Polymer Microspheres for Injectable Suspension). The Company intends to continue working with the U.S. Food and Drug Administration (FDA) on the development of Imagify.
“The withdrawal of the MAA is a difficult but necessary decision at this time. We are choosing to focus our resources on a pivotal trial in the U.S. to strengthen Imagify’s total data package for future partnering discussions and global regulatory submissions,” said Mark Leuchtenberger, President and Chief Executive Officer of Acusphere. “The withdrawal of the MAA in Europe does not affect the status of Imagify’s Special Protocol Assessment with the FDA and we remain committed to completing its clinical development.”
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