U.S. Food & Drug Administration (FDA) Daily Digest Bulletin

Update : 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Sat, 11 Oct 2008 00:44:51 -0500 (CDT)
Subject: The FDA this Week: Andy's Take -- FDA: Cough and Cold Medicines for Children

The FDA this Week: Andy's Take -- FDA: Cough and Cold Medicines for Children
Fri, 10 Oct 2008 22:57:00 -0500

As we approach the cold weather, you may see your kids sniffling more, having sore throats and stuffy noses. Choosing the appropriate remedy from a wide variety of over-the-counter medications is an important choice for parents. Over the past year there has been a lot of communication about whether or not these products should be used to treat children. The rules for marketing many of these products were developed many years ago. These rules do not always require that the products be studied in children to show whether they work for children but instead allow conclusions from experience of their effectiveness in adults.

My Take is that we must now understand scientifically that children are not just little adults. Current scientific standards must be used to assure these medications are effective and safe for your children in the correct prescribed dose to treat your child's cough and cold.

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U.S. Food & Drug Administration (FDA) Daily Digest Bulletin

Update : 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 10 Oct 2008 07:02:48 -0500 (CDT)
Subject: CDRH New Update

	FDA Home Page | CDRH Home Page | Search | A-Z Index

Date: October 10, 2008

The following new items were added to the CDRH web pages on October 9, 2008. Previous CDRH New Items can be found on the CDRHNew Page.

Federal Register: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Recall Regulations

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Update : 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 10 Oct 2008 07:46:49 -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.

Draft Guidance for Industry: Potency Tests for Cellular and Gene Therapy Products - 10/9/2008

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Update : 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 10 Oct 2008 11:20:08 -0500 (CDT)
Subject: CFSAN Constituent Update October 10, 2008

* U.S. Food and Drug Administration *
* Center for Food Safety and Applied Nutrition *

CONSTITUENT UPDATE

Constituent Updates are also available on the web at http://www.cfsan.fda.gov/~dms/cfsupdat.html.

Announcing Availability of the new Employees FIRST Food Defense Awareness Training Kit for First-Line Employees

The U.S. Food and Drug Administration (FDA) in collaboration with the Center for Disease Control (CDC) and U.S. Department of Agriculture (USDA) will launch its food defense awareness training kit for First-Line Employees in the food and agriculture industry from farm to table. The FIRST training kit is the second in a line of Food Defense Awareness Materials. ALERT, a program that was issued in July 2006, also focuses on prevention and identifies key points that supervisors and managers in industry and businesses can use to raise awareness of food defense issues and decrease the risks of intention food contamination.

Employees FIRST is a food defense awareness initiative for employees that food industry management can include in their ongoing food defense training programs.  FIRST will educate front-line industry workers from farm to table about the risk of intentional food contamination and the actions they can take to identify and reduce risks including:

F – FOLLOW company food defense plan and procedures
I – INSPECT your work area and surrounding areas
R – RECOGNIZE anything out of the ordinary
S – SECURE all ingredients, supplies and finished product
T – TELL management if you notice anything unusual or suspicious

Availability of Kit: Single copies of the kit will be available in English and Spanish. The kit is packaged in a self-mailer and it includes: 1 DVD; 4-color front and back poster in English and Spanish; and on-screen instructions for use. In addition, a web-ready version will be made available late October 2008. Copies of the kit may be obtained by ordering online from the Food Defense & Terrorism website (http://www.cfsan.fda.gov/fooddefense) or an email to marion.allen@fda.hhs.gov.

Contact: Marion V. Allen, Center for Food Safety and Applied Nutrition, Food Defense Oversight Team (HFS-007), Food and Drug Administration, 5100 Paint Branch Parkway, College Park, MD 20740, Phone: (301) 436-1584, email: marion.allen@fda.hhs.gov.

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Update : 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 10 Oct 2008 14:08:40 -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.

Supplement Approval: Antihemophilic Factor (Recombinant) Kogenate FS - Bayer HealthCare LLC.
Posted: 10/10/2008, Approval Date: 10/10/2008

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Update : 5
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 10 Oct 2008 14:51:49 -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.

FDA Licenses Drug to Prevent Joint Damage in Children with Hemophilia A
Posted: 10/10/2008

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Update : 6
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 10 Oct 2008 15:03:17 -0500 (CDT)
Subject: FDA Approves Rapaflo for the Treatment of Symptoms Due to an Enlarged Prostate Gland

FDA Approves Rapaflo for the Treatment of Symptoms Due to an Enlarged Prostate Gland
Fri, 10 Oct 2008 14:44:00 -0500

The U.S. Food and Drug Administration today approved Rapaflo (silodosin) capsules for the treatment of symptoms due to benign prostatic hyperplasia (BPH), a condition also known as an enlarged prostate.

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Update : 7
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 10 Oct 2008 16:38:02 -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: C1 Esterase Inhibitor (Human) (CINRYZE) - Lev Pharmaceuticals, Inc.
Posted: 10/10/2008, Approval Date: 10/10/2008

FDA Licenses for Marketing New Therapy for Rare Genetic Disease
Posted: 10/10/2008

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Update : 8
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 10 Oct 2008 08:02:48 -0500 (CDT)
Subject: Russell Stover Candies, Inc. Issues Hazelnut Allergy Alert for the 2 7/8 Oz Size Of Private Reserve Assorted Chocolates (October 9)

Russell Stover Candies, Inc. Issues Hazelnut Allergy Alert for the 2 7/8 Oz Size Of Private Reserve Assorted Chocolates (October 9)
Fri, 10 Oct 2008 07:40:00 -0500

The recalled product was distributed in the following states and cities: Texas, California, Louisiana, North Carolina, South Carolina, Virginia, Tennessee; Southaven, Mississippi; Billings, Montana; Sparks, Nevada; and Madison Heights, Michigan. An investigation determined 29 boxes of this candy may have been purchased by consumers, and up to another 188 boxes may have reached retail store locations. All the retail stores have been contacted to have the suspected product removed from the shelves.

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Update : 9
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 10 Oct 2008 12:03:38 -0500 (CDT)
Subject: FDA Licenses Drug to Prevent Joint Damage in Children with Hemophilia A

FDA Licenses Drug to Prevent Joint Damage in Children with Hemophilia A
Fri, 10 Oct 2008 11:51:00 -0500

The U.S. Food and Drug Administration today approved a new use for the blood product Kogenate FS to reduce the frequency of bleeding episodes and prevent joint damage in children with the most severe form of hemophilia.

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Update : 10
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 10 Oct 2008 14:03:15 -0500 (CDT)
Subject: Enforcement Report for October 8, 2008

Enforcement Report for October 8, 2008
Fri, 10 Oct 2008 12:52:00 -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.

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Update : 11
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 10 Oct 2008 15:03:15 -0500 (CDT)
Subject: FDA Launches Food Defense Awareness Training Kit for Employees in the Food Industry

FDA Launches Food Defense Awareness Training Kit for Employees in the Food Industry
Fri, 10 Oct 2008 14:44:00 -0500

Today the U.S. Food and Drug Administration in collaboration with the Centers for Disease Control and Prevention and the U.S. Department of Agriculture launched its food defense awareness training kit for first line food industry employees. The training targets these individuals because they can play an important role in helping to keep our nation's food supply safe, from the farm to the table.

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Update : 12
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 10 Oct 2008 17:03:09 -0500 (CDT)
Subject: FDA Licenses for Marketing New Therapy for Rare Genetic Disease

FDA Licenses for Marketing New Therapy for Rare Genetic Disease
Fri, 10 Oct 2008 16:05:00 -0500

The U.S. Food and Drug Administration today licensed for marketing the first product in the United States intended to protect people with hereditary angioedema (HAE), a rare and potentially life-threatening genetic disease. HAE affects about 6,000 to 10,000 individuals in the United States.

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GovDelivery, Inc. sending on behalf of U.S. Food & Drug Administration (FDA) · 5600 Fishers Lane · Rockville MD 20857 · 800-439-1420

U.S. Food & Drug Administration (FDA) Daily Digest Bulletin

Update : 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 9 Oct 2008 08:07:21 -0500 (CDT)
Subject: CDER New 10/8/2008

October 8, 2008

• Drugs@FDA Downloadable Data Files (updated)
• New and Generic Drug Approvals
  • Avelox (moxifloxacin hydrochloride) Tablets, Bayer Pharmaceuticals Corp., Labeling Revision
  • Avelox In Sodium Chloride 0.8% In Plastic Container (moxifloxacin hydrochloride) I.V. Injection, Bayer Pharmaceuticals Corp., Labeling Revision
  • Factive (gemifloxacin mesylate) Tablets, Oscient Pharmaceuticals Corp., Labeling Revision
  • Floxin (ofloxacin) Tablets, Ortho McNeil-Janssen Pharmaceutical, Inc., Labeling Revision
  • Levaquin (levofloxacin) Oral Solution, Ortho McNeil-Janssen Pharmaceutical, Inc., Labeling Revision
  • Levaquin (levofloxacin) Tablets, Ortho McNeil-Janssen Pharmaceutical, Inc., Labeling Revision
  • Levaquin In Dextrose 5% In Plastic Container (levofloxacin) Injection, Ortho McNeil-Janssen Pharmaceutical, Inc., Labeling Revision
  • Noroxin (norfloxacin) Tablets, Merck & Co., Inc., Labeling Revision

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Update : 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 9 Oct 2008 08:12:50 -0500 (CDT)
Subject: CDRH New Update

	FDA Home Page | CDRH Home Page | Search | A-Z Index

Date: October 9, 2008

The following new items were added to the CDRH web pages on October 8, 2008. Previous CDRH New Items can be found on the CDRHNew Page.

	Federal Register: Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees
	Federal Register: Medical Devices; Hearing Aids; Technical Data Amendments; Confirmation of Effective Date

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Update : 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 9 Oct 2008 08:48:57 -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.

Vacancy Announcement - Supervisory Medical Officer, DEB/OBE
Posted: 10/9/2008

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Update : 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 9 Oct 2008 09:02:42 -0500 (CDT)
Subject: Consumer Alert: Possible Botulism Contamination in Frozen Salted Croaker (October 6)

Consumer Alert: Possible Botulism Contamination in Frozen Salted Croaker (October 6)
Thu, 09 Oct 2008 08:14:00 -0500

New York State Agriculture Commissioner alerted consumers not to eat Frozen Salted Croaker distributed by YS Trading Corp, Long Island City, New York because the product was uneviscerated. The Frozen Salted Croaker was sold in Hicksville, New York, Flushing, New York, and New Jersey in un-coded, unlabeled plastic bags.

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Update : 5
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 9 Oct 2008 09:32:13 -0500 (CDT)
Subject: FDA Data Standards Update - SPL Xforms Update - Version 1.00

Greetings,

This e-mail serves as notification of the availability of version 1.00 of the SPL Xforms.

The SPL xforms are available on the Global Submit's website which is accessible via this hyperlink:  http://www.fda.gov/oc/datacouncil/xforms.html.

 

Lonnie Smith
Project Manager

Structured Product Labeling Team

Medical Informatics Staff &

FDA Data Standards Council

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Update : 6
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 9 Oct 2008 10:05:36 -0500 (CDT)
Subject: U.S. Food & Drug Administration (FDA) CBER's Proposed and Final Rules Update

You are subscribed to CBER's Proposed and Final Rules for U.S. Food & Drug Administration (FDA). This information has recently been updated, and is now available.

FEDERAL REGISTER: Distribution of Certain Drug Products by Registered Blood Establishments and Comprehensive Hemophilia Diagnostic Treatment Centers That Qualify as Health Care Entities; Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992; Policies, Requirements and Administrative Procedures, Final Rule -10/9/2008

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Update : 7
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 9 Oct 2008 13:11:38 -0500 (CDT)
Subject: Drug Information Update- FDA Statement Following CHPA's Announcement on Nonprescription Over-the-Counter Cough and Cold Medicines in Children

 The Division of Drug Information (DDI) is CDER's focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA. 

The Consumer Healthcare Products Association (CHPA), an association that represents most of the makers of nonprescription over-the-counter (OTC) cough and cold medicines in children, recently announced that its members are voluntarily modifying the product labels for consumers of OTC cough and cold medicines to state "do not use" in children under 4 years of age. Additionally, the manufacturers are introducing new child-resistant packaging and new measuring devices for use with the products.

The U.S. Food and Drug Administration supports the voluntary actions by CHPA members to help prevent and reduce misuse and to better inform consumers about the safe and effective use of these products for children. The FDA continues to assess the safety and efficacy of these products and to revise its OTC monograph (list of approved ingredients and amounts) for these medicines. Although this new labeling is inconsistent with the current monograph, FDA will not object, under the circumstances presented here, to the new label modification stating "do not use in children under 4," which reflects a more restrictive use of the drugs in children.

The steps that are being taken by CHPA will not affect the availability of the medicines, but this voluntary action will result in a transition period where the instructions for use of some OTC cough and cold medicines in children will be different from others. FDA does not typically request removal of OTC products with previous labeling from the shelves during a voluntary label change such as this one. Therefore, some medicines will have the new recommendation "do not use" for children under 4 years of age, while others will instruct that they not be used for children under 2 years of age. If parents or caregivers have or purchase a product that does not have the voluntarily-modified labeling, FDA recommends that they should adhere to the dosage instructions and warnings on the label that accompanies the medication. They should not, under any circumstances, give adult medications to children. If parents or caregivers have questions or are just not sure about how to use a product, they should consult with their doctor or pharmacist.

For more information, please visit: http://www.fda.gov/bbs/topics/NEWS/2008/NEW01899.html

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Update : 8
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 9 Oct 2008 04:03:05 -0500 (CDT)
Subject: FDA Statement Following CHPA's Announcement on Nonprescription Over-the-Counter Cough and Cold Medicines in Children

FDA Statement Following CHPA's Announcement on Nonprescription Over-the-Counter Cough and Cold Medicines in Children
Thu, 09 Oct 2008 03:14:00 -0500

The steps that are being taken by CHPA will not affect the availability of the medicines, but this voluntary action will result in a transition period where the instructions for use of some OTC cough and cold medicines in children will be different from others. FDA does not typically request removal of OTC products with previous labeling from the shelves during a voluntary label change such as this one. Therefore, some medicines will have the new recommendation "do not use" for children under 4 years of age, while others will instruct that they not be used for children under 2 years of age. If parents or caregivers have or purchase a product that does not have the voluntarily-modified labeling, FDA recommends that they should adhere to the dosage instructions and warnings on the label that accompanies the medication. They should not, under any circumstances, give adult medications to children. If parents or caregivers have questions or are just not sure about how to use a product, they should consult with their doctor or pharmacist.

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Update : 9
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 9 Oct 2008 09:02:38 -0500 (CDT)
Subject: Arnold Foods Company, Inc. Issues Allergy Alert on Undeclared Nuts in Brownberry Whole Grains Bread 100 Percent Whole Wheat (October 8)

Arnold Foods Company, Inc. Issues Allergy Alert on Undeclared Nuts in Brownberry Whole Grains Bread 100 Percent Whole Wheat (October 8)
Thu, 09 Oct 2008 08:14:00 -0500

The product being recalled has a green twist tie with a code date of "Oct 11" printed on the bread bag. No other Arnold brand or Brownberry brand products are affected.

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Update : 10
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 9 Oct 2008 10:03:42 -0500 (CDT)
Subject: Drug Shortages: Current Drug Shortages; Ultra-TechneKow DTE (Technetium Tc 99m Generator) NDA 17-243

Drug Shortages: Current Drug Shortages; Ultra-TechneKow DTE (Technetium Tc 99m Generator) NDA 17-243
Thu, 09 Oct 2008 08:25:00 -0500

See Related information section for updated Letter from Mallinckrodt

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Update : 11
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 9 Oct 2008 10:03:45 -0500 (CDT)
Subject: Consumer Alert: Undeclared Sulfites in Shad Raisins (October 6)

Consumer Alert: Undeclared Sulfites in Shad Raisins (October 6)
Thu, 09 Oct 2008 09:14:00 -0500

New York State Agriculture Commissioner alerted consumers that Fatima Brothers Inc. of Maspeth, New York is recalling Shad Raisins due to the presence of undeclared sulfites. The recalled Shad Raisins were packaged in uncoded, 7-ounce plastic bags. Shad Raisins were distributed in New York City.

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Update : 12
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 9 Oct 2008 13:03:36 -0500 (CDT)
Subject: Recalls and Melamine Contamination

Recalls and Melamine Contamination
Thu, 09 Oct 2008 12:44:00 -0500

FDA has increased inspections and product testing in response to the melamine contamination problem that originated in Chinese dairy products.

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Update : 13
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 9 Oct 2008 15:52:09 -0500 (CDT)
Subject: FDA MedWatch- OTC Cough and Cold Medicines- Product Labels Being Modified To State " Do Not Use" In Children Under 4 Years Of Age

FDA notified healthcare professionals and consumers that the Consumer Healthcare Products Association (CHPA) is voluntarily modifying the product labels for consumers of over the counter (OTC) cough and cold medicines to state "do not use" in children under 4 years of age. FDA supports CHPA members to help prevent and reduce misuse and to better inform consumers about the safe and effective use of these products for children. FDA continues to assess the safety and efficacy of these products and to revise its OTC list of approved ingredients and amounts for these medicines. Parents and care givers should adhere to the dosage instructions and warnings on the label that accompanies OTC cough and cold medications before giving the product to children, and should consult their healthcare professionals if they have any questions or concerns.

 

Read the entire 2008 MedWatch Safety Summaries, including a link to the FDA Press Release regarding the above issue at:

http://www.fda.gov/medwatch/safety/2008/safety08.htm#CoughCold

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GovDelivery, Inc. sending on behalf of U.S. Food & Drug Administration (FDA) · 5600 Fishers Lane · Rockville MD 20857 · 800-439-1420

U.S. Food & Drug Administration (FDA) Daily Digest Bulletin

Update : 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 8 Oct 2008 07:38:19 -0500 (CDT)
Subject: CDRH New Update

	FDA Home Page | CDRH Home Page | Search | A-Z Index

Date: October 8, 2008

The following new items were added to the CDRH web pages on October 7, 2008. Previous CDRH New Items can be found on the CDRHNew Page.

	Summary Information for: Hoya iSpheric™ Model YA-60BB Intraocular Lens
	Summary Information for: XIENCE™ V Everolimus Eluting Coronary Stent System and PROMUS™ Everolimus Eluting Coronary Stent System

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Update : 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 8 Oct 2008 08:32:40 -0500 (CDT)
Subject: FDA Warning Letters Update

You are subscribed to FDA Warning Letters for U.S. Food & Drug Administration (FDA). This information has recently been updated, and is now available.

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Update : 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 8 Oct 2008 09:26:39 -0500 (CDT)
Subject: FDA Warning Letters Update

You are subscribed to FDA Warning Letters for U.S. Food & Drug Administration (FDA). This information has recently been updated, and is now available.

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Update : 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 8 Oct 2008 13:47:12 -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.

Influenza Virus Vaccine 2008/2009 Season Lot Release Status - Update
Posted: 10/8/2008

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GovDelivery, Inc. sending on behalf of U.S. Food & Drug Administration (FDA) · 5600 Fishers Lane · Rockville MD 20857 · 800-439-1420