March 30th, 2010
• FDA Issues Complete Response Letter For Certriad
• U.K.’s NICE Goes Easier on Dronedarone
• U.S. Justice Dep’t & SEC Look Into Boston Scientific ICD Recall
Larry Husten, PHD
FDA Issues Complete Response Letter For Certriad: The FDA issued a complete response letter for the NDA for Certriad, Abbot’s and AstraZeneca’s combination pill composed of rosuvastatin and fenofibric acid delayed release. The companies did not release any details of the letter, but analysts think it will mean the drug’s approval will likely be delayed until next year at least. (Press release.)
U.K.’s NICE Goes Easier on Dronedarone: Following an earlier negative recommendation, the U.K.’s National Institute for Health and Clinical Excellence has revised its preliminary recommendations for dronedarone. The new draft guidance recommends the use of the drug only as a second-line therapy in high-risk AF patients without unstable NYHA class III or class IV heart failure. (NICE appraisal consultation document.)
U.S. Justice Dep’t & SEC Look Into Boston Scientific ICD Recall: The Wall Street Journal reports (subscription required) that the U.S. Department of Justice and the Securities and Exchange Commission are each undertaking an investigation of Boston Scientific’s recent recall of its ICDs. On Monday, the company released a transcript of a conference call with physicians in which the company explained the recall and provided assurances about the company’s future.
NEJM Journal Watch — Recent Cardiology Articles- Does Lowering High Childhood Lipid Levels Prevent Adverse Cardiovascular Events in Adulthood?
- Self-Expanding Supraannular Valve vs. Balloon-Expandable Valve in TAVR for Small Aortic Annulus
- A New TAVR Prosthesis for Aortic Regurgitation Shows Promise
- Aprocitentan, a Newly Approved Drug for Resistant Hypertension
- Preventive PCI of Vulnerable Plaques Linked to Fewer Cardiac Events