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
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