From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 21 Aug 2008 07:57:53 -0500 (CDT)
Subject: CDRH New Update
    |
| FDA Home Page | CDRH Home Page | Search | A-Z Index |  | |
 | ||
 | Date: August 21, 2008 |
The following new items were added to the CDRH web pages on August 20, 2008. Previous CDRH New Items can be found on the CDRHNew Page.
 | Consumer Information on: T-SPOT.TB - P070006 |  |
Update: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 21 Aug 2008 08:02:47 -0500 (CDT)
Subject: Warning on Certain Mussel Products from Bantry Bay Seafood
Warning on Certain Mussel Products from Bantry Bay Seafood
Thu, 21 Aug 2008 07:53:00 -0500
Getting sick can ruin your trip. FDA shares the guidance it gives to overseas inspectors to help them remain healthy while traveling abroad.
Update: 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 21 Aug 2008 14:31:04 -0500 (CDT)
Subject: What's New at CBER Update
You are subscribed to What's New at CBER for U.S. Food & Drug Administration (FDA). This information has recently been updated, and is now available.
Approval Information: Blood Grouping Reagents (Erytype S) - Biotest Medical Diagnostics GmbH
Posted: 8/21/2008, Approval Date: 8/14/2008
Substantially Equivalent 510(k) Device - Tango Optimo Automated Blood Bank Analyzer System
Posted: 8/21/2008, Clearance Date: 7/23/2008
Update: 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 21 Aug 2008 15:20:54 -0500 (CDT)
Subject: CDER New 8/21/2008
| ||||||||||||
August 21, 2008
- Drug Safety Oversight Board Meeting, July 17, 2008
- FDA issues an Early Communication About an Ongoing Safety Review of Ezetimibe/Simvastatin (marketed as Vytorin), Simvastatin (marketed as Zocor) and Ezetimibe (marketed as Zetia). Drug Information
- Guidance for Industry: Acute Bacterial Exacerbations of Chronic Bronchitis in Patients with Chronic Obstructive Pulmonary Disease: Developing Antimicrobial Drugs for Treatment [PDF]
- New and Generic Drug Approvals
- Abilify (aripiprazole) Intramuscular Injection, Otsuka Pharmaceutical Development and Commercialization, Inc., Labeling Revision
- Abilify (aripiprazole) Oral Solution, Otsuka Pharmaceutical Development and Commercialization, Inc., Labeling Revision
- Abilify (aripiprazole) Orally Disintegrating Tablets, Otsuka Pharmaceutical Development and Commercialization, Inc., Labeling Revision
- Abilify (aripiprazole) Tablets, Otsuka Pharmaceutical Development and Commercialization, Inc., Labeling Revision
- Geodon (ziprasidone hydrochloride) Capsules, Pfizer, Inc., Labeling Revision
- Geodon (ziprasidone mesylate) Intramuscular Injection, Pfizer, Inc., Labeling Revision
- Invega (paliperidone) Extended-Release Tablets, Johnson & Johnson Pharmaceutical Research & Development, LLC, Labeling Revision
- Navane (thiothixine) Capsules, Pfizer, Inc., Labeling Revision
- Risperdal (risperidone) Oral Solution, Johnson & Johnson Pharmaceutical Research & Development, LLC, Labeling Revision
- Risperdal (risperidone) Orally Disintegrating Tablets, Johnson & Johnson Pharmaceutical Research & Development, LLC, Labeling Revision
- Risperdal (risperidone) Tablets, Johnson & Johnson Pharmaceutical Research & Development, LLC, Labeling Revision
- Risperdal Consta (risperidone) Intramuscular Injection, Johnson & Johnson Pharmaceutical Research & Development, LLC, Labeling Revision
- Seroquel (quetiapine fumarate) Tablets, AstraZeneca Pharmaceuticals, LP, Labeling Revision
- Seroquel XR (quetiapine fumarate) Extended-Release Tablets, AstraZeneca Pharmaceuticals, LP, Labeling Revision
- Symbyax (fluoxetine hydrochloride and olanzapine) Capsules, Eli Lilly and Co., Labeling Revision
- Zyprexa (olanzapine) Intramuscular Injection, Eli Lilly and Co., Labeling Revision
- Zyprexa (olanzapine) Tablets, Eli Lilly and Co., Labeling Revision
- Zyprexa Zydis (olanzapine) Orally Disintegrating Tablets, Eli Lilly and Co., Labeling Revision
- USP Chapter <467> Residual Solvents - Additional Information
Update: 5
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 21 Aug 2008 16:27:06 -0500 (CDT)
Subject: CFSAN Constituent Update August 21, 2008
* U.S. Food and Drug Administration * CONSTITUENT UPDATE Constituent Updates are also available on the web at http://www.cfsan.fda.gov/~dms/cfsupdat.html.
* Center for Food Safety and Applied Nutrition *
August 21, 2008
FDA Announces Final Rule Amending the Food Additive Regulations to Allow for the Irradiation of Fresh Iceberg Lettuce and Fresh Spinach
The Food and Drug Administration (FDA) announced a final rule today amending the food additive regulations to provide for the safe use of ionizing radiation for the control of foodborne pathogens and extension of shelf-life in fresh iceberg lettuce and fresh spinach. FDA has determined that this use of ionizing radiation will not adversely affect the safety of the food.
This final rule is a partial response to a food additive petition (FAP 9M4697) that had been filed by The National Food Processors Association (now the Grocery Manufacturers' Association) on behalf of The Food Irradiation Coalition. In 2007, the petitioner requested a response to a part of the original scope of the petition while the remainder would remain under review. Specifically, the petitioner requested a response to amend the food additive regulations to provide for the safe use of ionizing radiation for the control of food-borne pathogens and extension of shelf-life in fresh iceberg lettuce and fresh spinach up to a maximum absorbed dose of 4.0 kilogray (kGy).
This final rule will permit the irradiation of fresh iceberg lettuce and fresh spinach to a maximum absorbed dose of 4.0 kGy, which is effective in reducing microbial pathogens that have been associated with these crops in the past.
There will be a 30-day period for submitting objections or a request for a hearing to Docket No. FDA-1999-F-2405] (formerly 1999F-5522). Electronic objections may be submitted to the Federal eRulemaking Portal at http://www.regulations.gov or written submissions may be sent to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852.
Additional information regarding the final rule is available by contacting Dr. Lane A. Highbarger, Center for Food Safety and Applied Nutrition (HFS-255), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-1204.
Questions and Answers about Final Rule on Irradiation of Fresh Iceberg Lettuce and Fresh Spinach August 21, 2008
Update: 6
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 21 Aug 2008 16:36:34 -0500 (CDT)
Subject: What's New at CBER Update
You are subscribed to What's New at CBER for U.S. Food & Drug Administration (FDA). This information has recently been updated, and is now available.
Approval Information: Reagent Red Blood Cells and Reagent Red Blood Cells For Use in Automated Systems (Biotestcell and Erytypecell) - Biotest Medical Diagnostics GmbH
Posted: 8/21/2008, Approval Date: 8/14/2008
Update: 7
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 21 Aug 2008 15:42:49 -0500 (CDT)
Subject: FDA MedWatch- Ezetimibe/Simvastatin (Vytorin); Simvastatin (Zocor); and Ezetimibe (Zetia) - Report Of SEAS Trial Of A Possible Association Between The Use Of Vytorin And A Potential Increased Incidence Of Cancer
FDA informed healthcare professionals that the Agency is investigating a report from the Simvastatin and Ezetimibe in Aortic Stenosis (SEAS) trial of a possible association between the use of Vytorin and a potentially increased incidence of cancer. Vytorin is a combination product of simvastatin and ezetimibe used to decrease the production of cholesterol by the liver and inhibit the absorption of cholesterol in the intestine to reduce LDL-cholesterol levels and reduce the risk of cardiovascular events. Recently, FDA obtained preliminary results from the SEAS trial. The clinical trial tested whether lowering LDL-cholesterol with Vytorin would reduce the risk of cardiovascular events in individuals with aortic stenosis. A lower overall cardiovascular risk was not found with Vytorin. However, there was an additional observation that a larger percentage of subjects treated with Vytorin were diagnosed with and died from all types of cancer combined when compared to placebo during the 5-year study.
FDA anticipates receiving a final SEAS study report in about 3 months and the Agency's review and evaluation of the clinical trial data and other relevant information should take approximately 6 months. FDA will communicate its conclusions and recommendations at that time. Healthcare professionals and caregivers should continue to monitor patients taking Vytorin and report side effects from the use of this drug to the Agency.
Read the complete MedWatch 2008 Safety Summary, including a link to the '"Early Communication About an Ongoing Safety Review of Ezetimibe/Simvastatin (marketed as Vytorin); Simvastatin (marketed as Zocor); and Ezetimibe (marketed as Zetia)", at:
http://www.fda.gov/medwatch/safety/2008/safety08.htm#ezetimibe2
This service is provided to you at no charge by U.S. Food & Drug Administration (FDA).
GovDelivery, Inc. sending on behalf of U.S. Food & Drug Administration (FDA) · 5600 Fishers Lane · Rockville MD 20857 · 800-439-1420
