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Imagify FDA Approval Status

FDA Approved: No
Brand name: Imagify
Generic name: perflubutane
Company: Acusphere Inc.
Treatment for: Diagnosis and Investigation

Imagify (perflubutane) is an investigational imaging agent intended to assess perfusion using ultrasound (or echocardiography) for the detection of coronary artery disease.

In February 2009, Acusphere Inc. announced the receipt of a Complete Response Letter from the U.S. Food and Drug Administration (FDA) advising the company that the New Drug Application (NDA) for Imagify had not been approved.

Development timeline for Imagify

Feb 18, 2009Acusphere Announces Change In Imagify Regulatory Strategy and Deferral of Near-Term Contractual Cash Payments
Dec 11, 2008Acusphere Announces Results of FDA Advisory Committee Meeting
Dec  8, 2008Acusphere, Inc. Announces Posting of Briefing Documents for FDA Cardio Renal Drugs Advisory Committee Meeting on Imagify
Oct 13, 2008Acusphere's Imagify to be Reviewed at FDA Advisory Committee Meeting on December 10, 2008
Jun 30, 2008Acusphere Announces FDA Acceptance of Imagify NDA for Detection of Coronary Artery Disease
Apr 29, 2008Acusphere Submits New Drug Application for FDA Approval of Imagify

Further information

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