Revised labeling approved for Cypher stent
A retrospective analysis by the FDA of more than 900 patients has found no increased risk of myocardial infarction with the use of overlapping Cypher stents (sirolimus-eluting coronary stent, Cordis Corp.), leading the agency to approve revised labeling for the product. Overlapping stents are used in patients with complex coronary artery disease when the blockage is too long for a single stent. Approximately 25% of procedures involve overlapping stents. The new labeling can be found at http://www.cypherusa.com/.
FDA’s Recent Exemptions: What Do They Mean as We Finalize DSCSA Implementation?
October 31st 2024Kala Shankle, Vice President of Regulatory Affairs with the Healthcare Distribution Alliance, and Ilisa Bernstein, President of Bernstein Rx Solutions, LLC, discussed recent developments regarding the Drug Supply Chain Security Act.
