Definity FDA Approval History
Last updated by Judith Stewart, BPharm on March 6, 2024.
FDA Approved: Yes (First approved July 31, 2001)
Brand name: Definity
Generic name: perflutren lipid microsphere
Dosage form: Injectable Suspension
Company: Lantheus Holdings, Inc.
Treatment for: Echocardiography
Definity (perflutren lipid microsphere) is an ultrasound contrast agent indicated, after activation, for use in adult and pediatric patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border.
- July 31, 2001 - FDA approves Definity for use in patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve delineation of the left ventricular endocardial border. Definity was the second of the second-generation ultrasound contrast agents to be approved after the approval of Optison (perflutren protein-type A microspheres) in 1997.
- October 10, 2007 - FDA issued new product labeling for Definity which included a Boxed Warning indicating that serious cardiopulmonary reactions, including fatalities have occurred during or within 30 minutes following Definity administration.
- May 12, 2008 - FDA issued new product labeling to modify Definity's benefit/risk assessment.
- October 24, 2011 - FDA approved labeling changes to the Definity product label including modifications to the Boxed Warning.
- November 17, 2020 - FDA approves Definity RT (Room Temperature) non-refrigerated product.
- March 1, 2024 - FDA approves Definity for use in pediatric patients with suboptimal echocardiograms.
Development timeline for Definity
| Date | Article |
|---|---|
| Mar 4, 2024 | Approval Lantheus Announces the FDA Approval of Definity (Perflutren Lipid Microsphere) for Pediatric Patients |
Further information
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