From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 16 Jun 2008 06:06:27 -0500 (CDT)
Subject: CDRH New Update
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| FDA Home Page | CDRH Home Page | Search | A-Z Index |  | |
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 | Date: June 16, 2008 |
The following new items were added to the CDRH web pages on June 13, 2008. Previous CDRH New Items can be found on the CDRHNew Page.
 | Anesthesiology and Respiratory Therapy Devices Panel Advisory Meeting, June 12, 2008 - Agenda, Roster, Briefing, Questions, Brief Summary |  | |
| Federal Register: Medical Devices; Medical Device Reporting; Baseline Reports (Direct final rule). | |  |
| Federal Register: Medical Devices; Medical Device Reporting; Baseline Reports; Companion to Direct Final Rule (Proposed rule). | | |
| Consumer Information on: Stratos LV and Stratos LV T Cardiac Resynchronization Therapy Pacemakers and Corox OTW BP and Corox OTW S BP Left Ventricular Pacing Leads - P070008 | |
Update: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 16 Jun 2008 15:06:17 -0500 (CDT)
Subject: FDA Requests Boxed Warnings on Older Class of Antipsychotic Drugs
FDA Requests Boxed Warnings on Older Class of Antipsychotic Drugs
Mon, 16 Jun 2008 14:38:00 -0500
The U.S. Food and Drug Administration today exercised its new authority under the Food and Drug Administration Amendments Act of 2007 (FDAAA) to require manufacturers of "conventional" antipsychotic drugs to make safety-related changes to prescribing information, or labeling, to warn about an increased risk of death associated with the off-label use of these drugs to treat behavioral problems in older people with dementia.
Update: 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 16 Jun 2008 18:48:17 -0500 (CDT)
Subject: CDER New 6/16/2008
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June 16, 2008
- FDA issues an Information for Healthcare Professionals sheet for antipsychotics. Drug Information
- FDA updates information on adverse event reports and heparin
- New and Generic Drug Approvals
- Advil Liqui-Gels (ibuprofen) Capsules, Wyeth Consumer Healthcare, Labeling Revision
- Advil Migraine Liqui-Gels (ibuprofen) Capsules, Wyeth Consumer Healthcare, Labeling Revision
- Advil PM (ibuprofen and diphenhydramine hydrochloride) Capsules, Wyeth Consumer Healthcare, Labeling Revision
- Advil PM (ibuprofen and diphenhydramine citrate) Tablets, Wyeth Consumer Healthcare, Labeling Revision
- Butorphanol Tartrate Injection, Apotex Corp., Control Supplement
- Children's Advil (ibuprofen) Chewable Tablets, Wyeth Consumer Healthcare, Labeling Revision
- Children's Advil (ibuprofen) Oral Suspension, Wyeth Consumer Healthcare, Labeling Revision
- Children's Advil - Flavored (ibuprofen) Oral Suspension, Wyeth Consumer Healthcare, Labeling Revision
- Escitalopram Oxalate Tablets, Lupin Pharmaceuticals, Inc., Tentative Approval
- Genotropin (somatropin [rDNA origin]) Injection, Pharmacia & Upjohn Co., New or Modified Indication
- Genotropin Preservative Free (somatropin [rDNA origin]) Injection, Pharmacia & Upjohn Co., New or Modified Indication
- Irbesartan and Hydrochlorothiazide Tablets, Mylan Pharmaceuticals, Inc., Tentative Approval
- Junior Strength Advil (ibuprofen) Chewable Tablets, Wyeth Consumer Healthcare, Labeling Revision
- K-Dur (potassium chloride) Extended-Release Tablets, Schering Corp., Labeling Revision
- Metoclopramide Hydrochloride Tablets, Ipca Laboratories, Ltd., Approval
- Nicorette (nicotine polacrilex) Gum, GlaxoSmithKline, Formulation Revision
- Nicorette (nicotine polacrilex) Gum, GlaxoSmithKline, Formulation Revision
- Nicorette (Mint) (nicotine polacrilex) Gum, GlaxoSmithKline, Formulation Revision
- Nicorette (Mint) (nicotine polacrilex) Gum, GlaxoSmithKline, Formulation Revision
- Pediatric Advil (ibuprofen) Oral Drops, Wyeth Consumer Healthcare, Labeling Revision
- Vytorin (ezetimibe and simvastatin) Tablets, MSP Singapore Company, LLC, Labeling Revision
Update: 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 16 Jun 2008 15:51:21 -0500 (CDT)
Subject: FDA MedWatch- Antipsychotics Associated With An Increased Risk Of Mortality In Elderly Patients Treated For Dementia-Related Psychosis
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FDA notified healthcare professionals that both conventional and atypical antipsychotics are associated with an increased risk of mortality in elderly patients treated for dementia-related psychosis. In April 2005, FDA notified healthcare professionals that patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death. Since issuing that notification, FDA has reviewed additional information that indicates the risk is also associated with conventional antipsychotics. Antipsychotics are not indicated for the treatment of dementia-related psychosis. The prescribing information for all antipsychotic drugs will now include the same information about this risk in a BOXED WARNING and the WARNING section.
Read the entire 2008 MedWatch Safety Summary, including a link to the FDA Information for Healthcare Professionals regarding this issue at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Antipsychotics
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