From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 1 May 2008 07:41:34 -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: May 1, 2008 |
The following new items were added to the CDRH web pages on April 30, 2008. Previous CDRH New Items can be found on the CDRHNew Page.
 | Federal Register: Towards an Artificial Pancreas: A Food and Drug Administration, National Institutes of Health, Juvenile Diabetes Research Foundation Public Workshop. |  |  |
| Federal Register: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Additional Listing Information for Medical Device Registration and Listing. | | |
Update: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 1 May 2008 08:42:00 -0500 (CDT)
Subject: CDER New 4/30/2008
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April 30, 2008
- Common Technical Document (CTD) Modules/Sections Corresponding to Summary Data Tables in Bioequivalence Submissions to ANDAs (updated)
- Drugs@FDA Downloadable Data Files (updated)
- FDA approves Amitiza (lubiprostone) for the treatment of irritable bowel syndrome with constipation in adult women aged 18 and over.
- Postmarketing Study Commitments (updated)
Update: 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 1 May 2008 09:03:49 -0500 (CDT)
Subject: FDA Completes Final Analysis of "Total Body Formula" and "Total Body Mega Formula" Products
FDA Completes Final Analysis of "Total Body Formula" and "Total Body Mega Formula" Products
Thu, 1 May 2008 08:02:00 -0500
The U.S. Food and Drug Administration's final analysis of certain flavors of "Total Body Formula" and "Total Body Mega Formula" has detected hazardous amounts of chromium.
Update: 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 1 May 2008 09:04:15 -0500 (CDT)
Subject: Enforcement Report for April 30, 2008
Enforcement Report for April 30, 2008
Thu, 1 May 2008 08:38:00 -0500
Weekly report by the Food and Drug Administration, Department of Health and Human Services. It contains information on actions taken in connection with agency Regulatory activities.
Update: 5
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 1 May 2008 14:06:52 -0500 (CDT)
Subject: U.S. Food & Drug Administration (FDA) CBER's Recalls, Withdrawals, Field Corrections & Notifications Update
You are subscribed to CBER's Recalls, Withdrawals, Field Corrections & Notifications for U.S. Food & Drug Administration (FDA). This information has recently been updated, and is now available.
Withdrawal of Albumin (Human) 5%, Talecris Biotherapeutics
Posted: 5/1/2008; Withdrawal Date: 4/30/2008
Update: 6
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 1 May 2008 15:22:16 -0500 (CDT)
Subject: Interstate Certified Shellfish Shippers Update May 2008
* * * Interstate Certified Shellfish Shippers List * * *
The monthly ICSSL update is now available for download at http://www.cfsan.fda.gov/~ear/shellfis.html.
May 2008 Update
Update: 7
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 1 May 2008 16:04:52 -0500 (CDT)
Subject: Drug Approved for Irritable Bowel Syndrome with Constipation
Drug Approved for Irritable Bowel Syndrome with Constipation
Thu, 1 May 2008 13:04:00 -0500
FDA has approved Amitza (lubiprostone) for the treatment of irritable bowel syndrome with constipation in adult women aged 18 and over
Update: 8
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 1 May 2008 16:05:03 -0500 (CDT)
Subject: Device Identifies Fatty Deposits in Coronary Arteries
Device Identifies Fatty Deposits in Coronary Arteries
Thu, 1 May 2008 13:04:00 -0500
A new medical device allows doctors to see the plaque buildup on the wall of coronary arteries. Many heart attacks occur when a fatty coronary plaque ruptures, forming dangerous blood clots.
Update: 9
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 1 May 2008 16:05:09 -0500 (CDT)
Subject: Combating Antibiotic Resistance
Combating Antibiotic Resistance
Thu, 1 May 2008 13:04:00 -0500
Misuse and overuse of antibiotics have contributed to antibiotic resistance, a phenomenon that reduces or eliminates the effectiveness of antibiotics.
Update: 10
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 1 May 2008 16:13:47 -0500 (CDT)
Subject: FDA Data Standards Update - SPL Terminology Update - Marketing Categories
Greetings,
The FDA Data Standards Council's SPL web page was updated Thursday, May 1, 2008, to add terms and codes for marketing categories.
The new terms and codes are located on this web page: http://www.fda.gov/oc/datacouncil/term.html#marcat.
.
Lonnie Smith
Project Manager
Food and Drug Administration
Update: 11
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 2 May 2008 07:48:02 -0500 (CDT)
Subject: CDER New 5/1/2008
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May 1, 2008
- Guidance for Industry: Comprehensive List of Guidance Documents
- Guidance for Industry: New/Revised/Withdrawn List for 2008
- New and Generic Drug Approvals
- Anastrozole Tablets, Zydus Pharma, Tentative Approval
- Ciclopirox Topical Gel, Nycomed US, Inc., Tentative Approval
- Ciprofloxacin Injection, Claris Lifesciences, Approval
- Donepezil Hydrochloride Tablets, Teva Pharma, Approval
- Escitalopram Oxalate Tablets, Zydus Pharma, Tentative Approval
- Granisetron Hydrochloride Injection, Ebewe Parenta, Approval
- Mepivacaine Hydrochloride Injection, Hospira Inc., Approval
- Metoprolol Tartrate Injection, Hospira Inc., Approval
- Omeprazole Delayed-Release Capsules, Lek Pharm, Tentative Approval
- Optiray (Ioversol) Injection, Mallinckrodt, Labeling Revision
- Penicillin V Potassium Tablets, Aurobindo Pharma, Approval
- Sodium Chloride 0.9% in Plastic Container Injection, Mallinckrodt, Labeling Revision
- Trandolapril Tablets, Mylan Pharma, Approval
- Pediatric Exclusivity Statistics: Pediatric Exclusivity Labeling Changes (updated)
- Prescription Drug User Fee Act (PDUFA) Billable Products
(updated)
Update: 12
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 2 May 2008 09:03:28 -0500 (CDT)
Subject: Drug to be Discontinued: Tilade Inhaler (nedocromil sodium inhalation aerosol)
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Drug to be Discontinued: Tilade Inhaler (nedocromil sodium inhalation aerosol)
Fri, 2 May 2008 09:45:00 -0500
Dear Healthcare Professional Letter is available.
Update: 13
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 2 May 2008 16:18:07 -0500 (CDT)
Subject: FDA Data Standards Update - UNII Update
The FDA Data Standards Council's website was updated Friday, May 2, 2008, to include an update to the list of Unique Ingredient Identifiers (UNIIs).
Hyperlinks to the updated list of UNIIs can be found on either of these web pages:
Substance Registration System - Unique Ingredient Identifier: http://www.fda.gov/oc/datacouncil/SRS.htm
Structured Product Labeling Resources: http://www.fda.gov/oc/datacouncil/spl.html
Lonnie Smith
Project Manager
Food and Drug Administration
Update: 14
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 2 May 2008 17:03:56 -0500 (CDT)
Subject: Little Bay Baking Company Issues Nationwide Allergy Alert On Undeclared Soy In Corn Bread And Muffin Mix in 12.6 Ounce White Paper Tin Tie Bag Package (May 2)
Little Bay Baking Company Issues Nationwide Allergy Alert On Undeclared Soy In Corn Bread And Muffin Mix in 12.6 Ounce White Paper Tin Tie Bag Package (May 2)
Fri, 2 May 2008 16:33:00 -0500
Little Bay Baking Company of Newmarket, New Hampshire is recalling all bags of CORN BREAD AND MUFFIN MIX sold before May 2, 2008 because it contains undeclared soy. People who have an allergy or severe sensitivity to soy run the risk of serious or life-threatening allergic reaction if they consume these products.
Update: 15
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 1 May 2008 14:16:26 -0500 (CDT)
Subject: FDA MedWatch- Enbrel (etanercept)-Prescribing Information Revised To Include A Boxed Warning Regarding The Risk Of Infection, Including Tuberculosis
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Amgen and Wyeth Pharmaceuticals informed healthcare professionals of revisions to prescribing information for Enbrel. The revisions include a BOXED WARNING about infections, including serious infections leading to hospitalization or death that have been observed in patients treated with Enbrel. Infections have included bacterial sepsis and tuberculosis. The ADVERSE REACTIONS section of the label was updated to include information regarding global clinical studies and the rate of occurrence of tuberculosis in patients treated with Enbrel. Healthcare professionals should screen patients for latent tuberculosis infection before beginning Enbrel. Patients should be educated about the symptoms of infection and closely monitored for signs and symptoms of infection during and after treatment with the drug. Patients who develop an infection should be evaluated for appropriate antimicrobial treatment and, in patients who develop a serious infection, Enbrel should be discontinued.
Read the entire 2008 MedWatch Safety Summary, including a link to the manufacturer's Dear Healthcare Professional Letter regarding this issue at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Enbrel
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