Amersham Myoview diagnostic agent cited for off-label promotions in Aug. 21 FDA warning letter.
This article was originally published in The Gray Sheet
Executive Summary
AMERSHAM MYOVIEW PROMOTIONS FOR UNAPPROVED INDICATIONS are cited in a warning letter issued by FDA's Division of Drug Marketing, Advertising, & Communications Aug. 21. FDA maintains that Amersham is promoting the radiopharmaceutical diagnostic agent for the unapproved uses of pharmacologic stress testing and assessment of heart function when the technetium Tc99m tetrofosmin product is only approved for myocardial imaging under exercise and resting conditions.