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

UpDate : 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 16 Oct 2008 07:57:16 -0500 (CDT)
Subject: CDRH New Update

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

Date: October 16, 2008

The following new items were added to the CDRH web pages on October 15, 2008. Previous CDRH New Items can be found on the CDRHNew Page.

	Federal Register: Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
	Summary Information for: TAXUS™ Express2™ Paclitaxel-Eluting Coronary Stent System (Monorail, MR and Over-the-Wire, OTW) - In-Stent Restenosis (ISR) Indication

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UpDate : 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 16 Oct 2008 09:16:10 -0500 (CDT)
Subject: CDER New October 10-15

October 15, 2008

• Drugs@FDA Downloadable Data Files (updated)
• New pages for Rheumatology Therapeutics.

October 14, 2008

• CDER Organization Charts [HTML] [PDF] (updated)
• New and Generic Drug Approvals
  • AmBisome (amphotericin B) Liposome Injection, Astellas Pharma US, Inc., Labeling Revision
  • Cetirizine Hydrochloride Syrup, Cypress Pharmaceutical, Inc., Approval
  • Dantrium (dantrolene sodium) Injection, JHP Pharmaceuticals, Labeling Revision
  • Fosamax (alendronate sodium) Oral Solution, Merck & Co., Inc., Packaging Addition
  • Fosamax (alendronate sodium) Tablets, Merck & Co., Inc., Packaging Addition
  • Fosamax Plus D (alendronate sodium and cholecalciferol) Tablets, Merck & Co., Inc., Packaging Addition
  • Letairis (ambrisentan) Tablets, Gilead Sciences, Inc., Labeling Revision
  • Prinivil (lisinopril) Tablets, Merck Research Laboratories, Labeling Revision
  • Prinzide (lisinopril and hydrochlorothiazide) Tablets, Merck Research Laboratories, Labeling Revision
  • Prismasol Solutions Gambro Lundia AB, Formulation Revision
  • Rapflo (silodosin) Capsules, Watson Laboratories, Inc., Approval
  • Risperdal Consta (risperidone) Intramuscular Injection, Ortho-McNeil-Janssen Pharmaceutical, Inc., Labeling Revision
  • Risperidone Tablets, Aurobindo Pharma Ltd., Approval
  • Risperidone Tablets, Wockhardt Ltd., Approval
  • Seroquel XR (quetiapine fumarate) Extended-Release Tablets, AstraZeneca Pharmaceuticals LP, New or Modified Indication
  • Vaprisol (conivaptan hydrochloride) I.V. Injection, Astellas Pharma US, Inc., Formulation Revision

October 10, 2008

• Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) (updated)
• International Conference on Harmonization (ICH) Public Meeting, October 21, 2008, Rockville, Maryland: Meeting information and registration - (updated)
• Podcast Transcript - Measures Undertaken to Address Concerns about Marketing of Unapproved Drugs

 

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UpDate : 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 16 Oct 2008 10:14:08 -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.

Public Workshop: Adjuvants and Adjuvanted Preventative and Therapeutic Vaccines for Infectious Disease Indications
Posted: 10/16/2008; Meeting Dates: 12/2-3/2008

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UpDate : 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 16 Oct 2008 10:28:45 -0500 (CDT)
Subject: Improper Use of Decorative Contacts May Haunt You

Improper Use of Decorative Contacts May Haunt You
Thu, 16 Oct 2008 09:05:00 -0500

Halloween is a good time to remind people that improper use of non-prescription decorative contact lenses may harm your vision

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UpDate : 5
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 16 Oct 2008 14:11:50 -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.

Substantially Equivalent 510(k) Device - AMICUS® Separator: Software 3.1 with EDI Export - Fenwal Inc.
Posted:10/16/2008, Clearance Date: 10/2/2008

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UpDate : 6
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 16 Oct 2008 10:28:44 -0500 (CDT)
Subject: Use Caution With Ayurvedic Products

Use Caution With Ayurvedic Products
Thu, 16 Oct 2008 09:05:00 -0500

The presence of heavy metals in some Ayurvedic products makes them potentially harmful.

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UpDate : 7
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 16 Oct 2008 10:34:11 -0500 (CDT)
Subject: FDA MedWatch- Dextroamphetamine Sulfate 5mg Tablets- Drug Recall Due To The Potential For Oversized Tablets

Ethex Corp and FDA notified healthcare professionals of a voluntary recall of three lots of Dextroamphetamine Sulfate 5mg tablets. The product was recalled due to the potential presence of oversized tablets that may contain as much as twice the labeled amount of the active ingredient. Taking a higher than expected dose of Dextroamphetamine Sulfate may be associated with an increased risk of adverse effects such as tachycardia, hypertension, tremors, decreased appetite, headache, insomnia, dizziness, blurred vision, stomach upset, and drug mouth. Consumers and their caregivers should not use any Dextroamphetamine Sulfate tablets that appear to be oversized and should consult their healthcare professional with any questions.

Read the entire 2008 MedWatch Safety Summary, including a link to the manufacturer's recall notice regarding the above issue at:

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

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UpDate : 8
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 16 Oct 2008 16:03:35 -0500 (CDT)
Subject: FDA Approves Updated Labeling for Psoriasis Drug Raptiva

FDA Approves Updated Labeling for Psoriasis Drug Raptiva
Thu, 16 Oct 2008 15:33:00 -0500

The U.S. Food and Drug Administration announced labeling changes, including a Boxed Warning, to highlight the risks of life-threatening infections, including progressive multifocal leukoencephalopathy (PML), with the use of Raptiva (efalizumab). The labeling changes are based on the FDA's post-market surveillance. The FDA is also requiring the submission of a Risk Evaluation and Mitigation Strategy (REMS), which will include a Medication Guide for patients and a timetable for assessment of the REMS.

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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

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

UpDate : 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 15 Oct 2008 07:45:38 -0500 (CDT)
Subject: CDRH New Update

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

Date: October 15, 2008

The following new items were added to the CDRH web pages on October 14, 2008. Previous CDRH New Items can be found on the CDRHNew Page.

Information on Cell Phones (Updated)

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UpDate : 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 15 Oct 2008 09:24:45 -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, 15 Oct 2008 11:01:48 -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, DCEPTO/OCTGT
Posted: 10/15/2008

Approval Information: Meningococcal Polysaccharide (Serogroups A, C, Y and W-135) Diphtheria Toxoid Conjugate Vaccine (Menactra) - Sanofi Pasteur Inc.
Posted: 10/15/2008, Approval Date: 10/7/2008

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UpDate : 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 15 Oct 2008 17:18:21 -0500 (CDT)
Subject: FDA Data Standards Update - SPL Stylesheet Version 4.0.3 & SPL Terminology Updates

Greetings,

The FDA Data Standards Council's SPL web page was updated Wednesday, October 15, 2008, to include:

1. Updated version of the SPL stylesheet (version 4.0.3) http://www.fda.gov/oc/datacouncil/StyleSheet_V4_0_3.zip (see release notes for list of changes)
2. Added outdated version (4.0.2) of SPL stylesheet to SPL stylesheet archives http://www.fda.gov/oc/datacouncil/stylesheet_archive.zip
3. UNII zip file:  (added new UNIIs)  http://www.fda.gov/oc/datacouncil/UNIIs.zip
4. Terminology lists (XML version):  http://www.fda.gov/oc/datacouncil/terminology_lists.zip  (Added updated UNII XML file and additional route of administration:  occlusive dressing technique and concept code.)
5. Replace telephone numbers under Contact Information heading with SPL e-mail address on this web page:  http://www.fda.gov/oc/datacouncil/spl.html 

 

 

Lonnie Smith

Project Manager

FDA Data Standards Council

 

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UpDate : 5
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 15 Oct 2008 15:03:25 -0500 (CDT)
Subject: Enforcement Report for October 15, 2008

Enforcement Report for October 15, 2008
Tue, 14 Oct 2008 12:59:00 -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 : 6
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 15 Oct 2008 15:03:29 -0500 (CDT)
Subject: FDA Creates Web Page with Drug Safety Information for Patients, Health Care Professionals

FDA Creates Web Page with Drug Safety Information for Patients, Health Care Professionals
Wed, 15 Oct 2008 15:00:00 -0500

Consumers and health care professionals can now go to a single page on the U.S. Food and Drug Administration's Web site to find a wide variety of safety information about prescription drugs

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UpDate : 7
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 15 Oct 2008 15:03:32 -0500 (CDT)
Subject: ETHEX Corporation Voluntarily Recalls Three Lots of Dextroamphetamine Sulfate 5mg Tablets Due to the Potential for Oversized Tablets (October 15)

ETHEX Corporation Voluntarily Recalls Three Lots of Dextroamphetamine Sulfate 5mg Tablets Due to the Potential for Oversized Tablets (October 15)
Wed, 15 Oct 2008 14:19:00 -0500

ETHEX Corporation announced today that it has voluntarily recalled three specific lots (77946, 81141 and 81142) of Dextroamphetamine Sulfate 5 mg tablets, as a precaution, due to the possible presence of oversized tablets. Oversized tablets may contain as much as about twice the labeled amount of the active ingredient. The recalled lots were distributed by ETHEX Corporation under an "ETHEX" label between January 2007 and May 2008. The 5 mg product is an orange round tablet debossed with "ETHEX" and "311" on one side.

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UpDate : 8
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 15 Oct 2008 17:08:59 -0500 (CDT)
Subject: FDA Information Update for Health Professionals - October 15, 2008

U.S. Food and Drug Administration

Office of Special Health Issues

5600 Fishers Lane, HF-12

Rockville, Maryland 20857

 

Dear Colleague,

 

As part of our ongoing efforts to keep you informed about FDA issues, we want to make you aware of recent safety information, product approvals, and upcoming meetings.  We have included a list of the issues, a brief summary of each issue, and links to detailed information on the FDA Web site. 

 

PRODUCT SAFETY INFORMATION:

 

ETHEX Corporation Voluntarily Recalls Three Lots of Dextroamphetamine Sulfate 5mg Tablets Due to the Potential for Oversized Tablets  (October 15)

ETHEX Corporation announced today that it has voluntarily recalled three specific lots (77946, 81141 and 81142) of Dextroamphetamine Sulfate 5 mg tablets, as a precaution, due to the possible presence of oversized tablets. Oversized tablets may contain as much as about twice the labeled amount of the active ingredient. The recalled lots were distributed by ETHEX Corporation under an "ETHEX" label between January 2007 and May 2008. The 5 mg product is an orange round tablet debossed with "ETHEX" and "311" on one side.

 

 

PRODUCT APPROVALS:

 

FDA Licenses for Marketing New Therapy for Rare Genetic Disease (October 10)

The FDA 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.  The product, called Cinryze, is licensed for the prevention of HAE attacks, which can occur spontaneously or during stress, surgery, or infection in patients diagnosed with the disease.

 

FDA Approves Rapaflo for the Treatment of Symptoms Due to an Enlarged Prostate Gland (October 10)

The FDA approved Rapaflo (silodosin) capsules for the treatment of symptoms due to benign prostatic hyperplasia (BPH), a condition also known as an enlarged prostate.

 

FDA Licenses Drug to Prevent Joint Damage in Children with Hemophilia A (October 10)

The FDA 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.

 

FDA Approves Use of Temporary Pump to Assist Heart's Right Side (October 7)
The FDA approved a Humanitarian Device Exemption (HDE) for the first heart pump that provides certain critically ill patients with temporary support for the right side of their heart. The CentriMag Right Ventricular Assist System is intended for patients requiring support for the heart's right ventricle, which passes oxygen-depleted blood to the lungs to be refreshed with oxygen.

 

FDA and PATH Malaria Vaccine Initiative Announce Research Collaboration (October 7)
The FDA has announced a collaboration with the PATH Malaria Vaccine Initiative (PATH-MVI) to develop laboratory tests to better predict the level of safety and effectiveness of experimental malaria vaccines before they are used in human clinical trials.

 

ANNOUNCEMENTS:

 

FDA Creates Web Page with Drug Safety Information for Patients, Health Care Professionals (October 15)
Consumers and health care professionals can now go to a single page on the U.S. Food and Drug Administration's Web site to find a wide variety of safety information about prescription drugs. The Web page was developed in accordance with Section 915 of the Food and Drug Administration Amendments Act of 2007 (FDAAA) and contains links to, among other things, the following:

drug labeling, including patient labeling, professional labeling, and patient package inserts

a searchable database of postmarket studies that provide the FDA with additional information about a drug's safety, efficacy, or optimal use

Clinicaltrials.gov, a searchable database of clinical trials

drug-specific safety information, including safety sheets with the latest information about the drug as well as related FDA press announcements, fact sheets, and drug safety podcasts

 

Visit the new website at http://www.fda.gov/cder/drugSafety.htm.

 

Unapproved Drugs: Drugs Marketed in the United States That Do Not Have Required FDA Approval (October 15)

The FDA has launched a new, improved marketed unapproved drug Web site with a section particularly for health care professionals. The site explains the risks posed by unapproved drugs and gives helpful information on how to protect patients.

 

The site includes:

Video and audio programs, given by FDA physicians and regulators that can be accessed online or downloaded

Questions and answers, public health advisories, and other documents

Enforcement actions taken by FDA (by drug class and by firms)

Background information about marketed unapproved drugs

FDA's initiative against marketed unapproved drugs

 

Visit the website at http://www.fda.gov/cder/drug/unapproved_drugs/default.htm

 

FDA Statement Following CHPA's Announcement on Nonprescription Over-the-Counter Cough and Cold Medicines in Children (October 8)

The U.S. Food and Drug Administration announced on October 8 that it supports the voluntary actions by the Consumer Healthcare Products Association members to  modify the product labels for consumers of over-the-counter 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. 

 

UPCOMING MEETINGS:                                                                                                                                                                                                                     

Preparation for International Conference on Harmonization Meetings in Brussels, Belgium

DATE: October 21, 3:00 p.m.
LOCATION: 5600 Fishers Lane, 3rd Floor, Conf. Rooms D and E, Rockville, MD.
CONTACT: Tammie Jo Bell, Office of the Commissioner, 301-827-0003. The purpose of the meeting is to solicit public input prior to the next Steering Committee and Expert Working Groups meetings in Brussels, Belgium, November 10 to 13, at which discussion of the topics underway and the future of ICH will continue. More Information

 

Endocrinologic and Metabolic Drugs Advisory Committee

DATE: October 21, 8:00 a.m.
LOCATION: Crowne Plaza Hotel, Washington DC-Silver Spring, 8777 Georgia Ave.,
Silver Spring, MD, (301) 589-0800
CONTACT: Paul Tran, R.Ph., 301-827-7001. On October 21, 2008, the committee will discuss the safety and efficacy of biologic license application (BLA) 125291, MYOZYME (algucosidase alfa) Genzyme Corporation, for the treatment of late onset Pompe disease.  More Information

 

Peripheral and Central Nervous System Drugs Advisory Committee

DATE AND TIME: October 23, 8:00 a.m.
LOCATION: Hilton Washington DC, Silver Spring, The Ballrooms, 8727 Colesville Road, Silver Spring, MD
CONTACT: Diem-Kieu Ngo, 301–827–7001

 

Joint Meeting of the Antiviral Drugs Advisory Committee and the Nonprescription Drugs Advisory Committee

DATE: October 29, 8:00 a.m.
LOCATION: Hilton The Ballrooms, 1750 Rockville Pike, Rockville, MD.
CONTACT: Paul Tran, Center for Drug Evaluation and Research, 301-827-6793.

The committee will provide advice on types of studies and trial designs needed for an influenza antiviral MedKit for the treatment or prophylaxis of pandemic influenza and discuss publicly the proposed development program that would support an application for such a MedKit.  Issues such as the role of personal MedKits, home stockpiling, non-prescription availability of influenza medications, and interfaces of home readiness with public health systems, will be raised in the course of the discussions. More Information

 

Antiviral Drugs Advisory Committee

DATE: October 30, 9:00 a.m.
LOCATION: Hilton Washington DC/Silver Spring, The Ballrooms, 1750 Rockville Pike, Rockville, MD
CONTACT: Paul Tran, Center for Drug Evaluation and Research, 301-827-6793. The meeting will be open to the public from 8 a.m. to 9 a.m., unless public participation does not last that long.  From 9 a.m. to 1 p.m., the meeting will be closed to permit discussion of current and future advances on antiviral drugs which will include the review of trade secret and/or confidential information. More Information

...

[Message clipped]  

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

UpDate : 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 14 Oct 2008 08:11:43 -0500 (CDT)
Subject: CDRH New Update

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

Date: October 14, 2008

The following new items were added to the CDRH web pages on October 10, 2008. Previous CDRH New Items can be found on the CDRHNew Page.

Federal Register: General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting.

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UpDate : 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 14 Oct 2008 12:35:29 -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: 10/14/2008

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UpDate : 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 14 Oct 2008 05:03:29 -0500 (CDT)
Subject: HUA XIA Food Trade USA, Inc. Recalls YILI Brand Sour Milk Drink and YILI Brand Pure Milk Drink, Because of Possible Health Risk (October 10)

HUA XIA Food Trade USA, Inc. Recalls YILI Brand Sour Milk Drink and YILI Brand Pure Milk Drink, Because of Possible Health Risk (October 10)
Tue, 14 Oct 2008 04:44:00 -0500

HUA XIA Food Trade USA, Inc. of Flushing, NY, is recalling YILI Brand Sour Milk Drink packaged in 250ml flexible paperboard boxes (all codes and all lots are affected) and YILI Brand Pure Milk Drink packaged in 250ml flexible paperboard boxes (all codes and all lots are affected) because it may be contaminated with melamine.

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UpDate : 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 14 Oct 2008 08:02:59 -0500 (CDT)
Subject: Measures Undertaken to Address Concerns about Marketing of Unapproved Drugs

Measures Undertaken to Address Concerns about Marketing of Unapproved Drugs
Fri, 10 Oct 2008 08:16:00 -0500

Measures undertaken to Address Concerns about Marketing of Unapproved Drugs

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UpDate : 5
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 14 Oct 2008 09:03:03 -0500 (CDT)
Subject: Barry Callebaut USA LLC Issues Allergen Alert on Undeclared Milk Protein in Kroger Value Semi Sweet Chocolate Chips (October 10)

Barry Callebaut USA LLC Issues Allergen Alert on Undeclared Milk Protein in Kroger Value Semi Sweet Chocolate Chips (October 10)
Tue, 14 Oct 2008 08:36:00 -0500

Barry Callebaut USA LLC is conducting a voluntary recall on its product sold by Kroger Stores under the brand "Kroger Value Semi Sweet Chocolate Chips", 12 oz., UPC Code is 11110–86603 and "sell by" date May 30, 2010, as the product may contain undeclared milk protein. The "sell by" date is found printed in black on the end of the bag. People with allergies or severe sensitivity to milk protein may be at risk of serious or life-threatening allergic reaction if they consume this product.

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UpDate : 6
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 14 Oct 2008 14:03:35 -0500 (CDT)
Subject: JFC International, Inc. Issues Allergy Alert on Undeclared Sulfite in "Kyosai Sengiri Daikon" Dried Radish (October 10)

JFC International, Inc. Issues Allergy Alert on Undeclared Sulfite in "Kyosai Sengiri Daikon" Dried Radish (October 10)
Tue, 14 Oct 2008 13:36:00 -0500

JFC International, Inc. is recalling all products of Kyosai Sengiri Daikon (40/3.50z) due to the present of undeclared sulfite. People who have an allergy or severe sensitivity to sulfite run the risk of life-threatening allergic reaction if they consume this product.

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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