This update is in follow-up to the FDA Drug Safety Communication on July 21, 2011 about Multaq (dronedarone) and increased risk of death and serious cardiovascular events  Safety Announcement Data Summary  Safety Announcement [12-19-2011] The U.S. Food and Drug Administration (FDA) has completed a safety review of the heart drug Multaq (dronedarone). This…
Summary Information for: AtriCure Synergy Ablation System
Issued December 15, 2011 Approval Order Summary Labeling Other Consumer Information This document is in a Portable Document Format (PDF). Acrobat Reader is required to read this document. Updated December 19, 2011
Consumer Information on: AtriCure Synergy Ablation System
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Draft Guidance for Industry and Food and Drug Administration Staff
DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Document issued on: December 19, 2011 You should submit comments and suggestions regarding this draft document within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit written comments to the Division of Dockets…
FDA Drug Safety Communication: Revised dose limitation for Zocor (simvastatin) when taken with amiodarone
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Selective Serotonin Reuptake Inhibitor (SSRI) Antidepressants: Drug Safety Communication
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FDA Drug Safety Communication: Selective serotonin reuptake inhibitor (SSRI) antidepressant use during pregnancy and reports of a rare heart and lung condition in newborn babies
Safety AnnouncementAdditional Information for PatientsAdditional Information for Healthcare ProfessionalsData Summary  Public Health Advisory in July 2006 on this potential risk was based on a single published study. Since then, there have been conflicting findings from new studies evaluating this potential risk, making it unclear whether use of SSRIs during pregnancy can cause PPHN.  …
November 2011
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Draft Guidance for Industry and FDA Staff- Humanitarian Use Device (HUD) Designations
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Gastric Banding
Gastric banding is a surgical procedure to reduce the size of the stomach for weight loss. In this procedure, a silicone band is placed around the upper portion of the stomach to create a small pouch. Afterwards, the stomach is smaller, so people feel full faster, eat less and lose weight.  A gastric band…