FDA Approval Activities for this Drug…

DEFINITY Vial for (Perflutren Lipid Microsphere) Injectable Suspension, Bristol-Myers Squibb Medical Imaging, NDA 21-064/SCM-004 1/30/03 2/12/03 DEFINITY Vial for (Perflutren Lipid Microsphere) Injectable Suspension, Bristol-Myers Squibb Medical Imaging, NDA 21-064/SLR-002 7/8/02 7/9/02 Definity, Bristol-Myers Squibb Medical Imaging, NDA 21-064/SLR-001 2/21/02 2/21/02 Definity (perflutren Lipid Microsphere) Injectable Suspension, DuPont Company NDA 21-064 7/31/01 05/08/03 11/1/01 Definity Indications: Use of activated Definity (perflutren Lipid Microsphere) Injectable Suspension in patients with suboptimal echocardiograms to opacity the left ventricular chamber and to improve the delineation of the left ventricular endocardial border.

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