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

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Message: 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 29 Apr 2008 05:46:14 -0500 (CDT)
Subject: CDRH New Update

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

Date: April 29, 2008

The following new items were added to the CDRH web pages on April 28, 2008. Previous CDRH New Items can be found on the CDRHNew Page.

Federal Register: Dental Devices: Classification of Encapsulated Amalgam Alloy and Dental Mercury and Reclassification of Dental Mercury; Issuance of Special Controls for Amalgam Alloy; Reopening of Comment Period.

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Message: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 29 Apr 2008 08:05:11 -0500 (CDT)
Subject: Coronary Artery Plaque Imaging Device Cleared by FDA

Coronary Artery Plaque Imaging Device Cleared by FDA
Tue, 29 Apr 2008 07:42:00 -0500

The U.S. Food and Drug Administration has cleared for marketing a device that a doctor can use to see inside a blood vessel to assess the fat content of the plaque which builds up on the wall of the coronary arteries.

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Message: 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 29 Apr 2008 18:04:32 -0500 (CDT)
Subject: FDA Approves Amitiza for IBS-C

FDA Approves Amitiza for IBS-C
Tue, 29 Apr 2008 17:45:00 -0500

The U.S. Food and Drug Administration has approved Amitiza (lubiprostone) for the treatment of Irritable Bowel Syndrome with Constipation (IBS-C) in adult women aged 18 and over.

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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

You have requested to receive a Daily Digest e-mail from U.S. Food & Drug Administration (FDA).

Message: 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 28 Apr 2008 06:21:27 -0500 (CDT)
Subject: CDRH New Update

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

Date: April 28, 2008

The following new items were added to the CDRH web pages on April 25, 2008. Previous CDRH New Items can be found on the CDRHNew Page.

FDA Clears Glove Made from New Type of Latex

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Message: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 28 Apr 2008 10:08:00 -0500 (CDT)
Subject: Actavis Totowa (formerly known as Amide Pharmaceutical, Inc.) recalls all lots of Bertek and UDL Laboratories Digitek (digoxin tablets, USP) as precaution (April 25)

Actavis Totowa (formerly known as Amide Pharmaceutical, Inc.) recalls all lots of Bertek and UDL Laboratories Digitek (digoxin tablets, USP) as precaution (April 25)
Mon, 28 Apr 2008 09:50:00 -0500

Actavis Totowa LLC, a United States manufacturing division of the international generic pharmaceutical company Actavis Group, is initiating a Class I nationwide recall of Digitek (digoxin tablets, USP, all strengths) for oral use. The products are distributed by Mylan Pharmaceuticals Inc., under a "Bertek" label and by UDL Laboratories, Inc. under a "UDL" label. The voluntary all lot recall is due to the possibility that tablets with double the appropriate thickness may have been commercially released. These tablets may contain twice the approved level of active ingredient than it appropriate.

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Message: 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 28 Apr 2008 10:19:25 -0500 (CDT)
Subject: Lifetime Brands Voluntarily Recalls Certain Items Nationwide from its Pfaltzgraff Villa della Luna pattern and Nautica J Class pattern (Red Only) Stoneware Dinnerware Product Lines (April 28)

Lifetime Brands Voluntarily Recalls Certain Items Nationwide from its Pfaltzgraff Villa della Luna pattern and Nautica J Class pattern (Red Only) Stoneware Dinnerware Product Lines (April 28)
Mon, 28 Apr 2008 09:50:00 -0500

Lifetime Brands, Inc., of Garden City, New York, today announced that, as a result of its internal compliance and independent product testing programs, it recently became aware that certain Pfaltzgraff Villa della Luna pattern and Nautica J Class pattern stoneware dinnerware products may exceed the Food and Drug Administration's guidance levels for lead and/or cadmium.

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Message: 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 28 Apr 2008 14:44:16 -0500 (CDT)
Subject: FDA MedWatch- Digitek (digoxin tablets)-Class I Recall Because Tablets May Contain Twice The Approved Level Of Active Ingredient

Actavis Totowa LLC notified healthcare professionals of a Class I nationwide recall of all strengths of Digitek, a drug used to treat heart failure and abnormal heart rhythms. The products are distributed by Mylan Pharmaceuticals Inc., under a “Bertek” label and by UDL Laboratories, Inc. under a “UDL” label. The product is being recalled due to the possibility that tablets with double the appropriate thickness may contain twice the approved level of active ingredient. The existence of double strength tablets poses a risk of digitalis toxicity in patents with renal failure. Digitalis toxicity can cause nausea, vomiting, dizziness, low blood pressure, cardiac instability and bradycardia. Several reports of illnesses and injuries have been reported. Patients should contact their healthcare professional with questions.

Read the entire 2008 MedWatch Safety Summary, including a link to the manufacturer's press release regarding this issue at:

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

 

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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

You have requested to receive a Daily Digest e-mail from U.S. Food & Drug Administration (FDA).

Message: 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 24 Apr 2008 05:41:10 -0500 (CDT)
Subject: CDRH New Update

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

Date: April 24, 2008

The following new items were added to the CDRH web pages on April 23, 2008. Previous CDRH New Items can be found on the CDRHNew Page.

Ophthalmic Devices Panel Advisory Meeting, April 24-25, 2008 - Agenda, Roster, Briefing, Questions

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Message: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 24 Apr 2008 09:06:48 -0500 (CDT)
Subject: FDA Proposes Recommendations for Two Animal Drug Funding Programs

FDA Proposes Recommendations for Two Animal Drug Funding Programs
Thu, 24 Apr 2008 09:04:00 -0500

The U.S. Food and Drug Administration has delivered recommendations to Congress for two programs that provide funding for the review of pioneer and generic animal drugs.

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Message: 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 24 Apr 2008 17:06:09 -0500 (CDT)
Subject: FDA Orders Pet Food Maker to Obtain Emergency Operating Permit

FDA Orders Pet Food Maker to Obtain Emergency Operating Permit
Thu, 24 Apr 2008 17:55:00 -0500

The U.S. Food and Drug Administration issued an order requiring that Evanger's Dog and Cat Food Co., Inc., in Wheeling, Ill., obtain an emergency permit from the FDA before its canned pet food products enter interstate commerce.

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Message: 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 24 Apr 2008 18:05:49 -0500 (CDT)
Subject: FDA Approves Relistor for Opioid-Induced Constipation

FDA Approves Relistor for Opioid-Induced Constipation
Thu, 24 Apr 2008 18:44:00 -0500

The U.S. Food and Drug Administration today approved Relistor (methylnaltrexone bromide) to help restore bowel function in patients with late-stage, advanced illness who are receiving opioids on a continuous basis to help alleviate their pain.

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Message: 5
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 25 Apr 2008 05:50:37 -0500 (CDT)
Subject: CDRH New Update

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

Date: April 25, 2008

The following new items were added to the CDRH web pages on April 24, 2008. Previous CDRH New Items can be found on the CDRHNew Page.

	Summary Information for: CONTAK RENEWAL® 3 AVT® Models M150, M155, M157 and M159
	Federal Register: Draft Guidance for Industry on Developing Coronary Drug Eluting Stents: Public Workshop.
	Federal Register: Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Labeling Regulations.
	Guidance for Industry and FDA Staff: Hemodialysis Blood Tubing Sets - Premarket Notification [510(k)] Submissions (Updated 4/24/2008)
	Federal Register: Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee; Notice of Postponement of Meeting.
	Summary Information for: Talent™ Abdominal Stent Graft System

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Message: 6
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 24 Apr 2008 15:53:24 -0500 (CDT)
Subject: MedWatch - January 2008 Drug Safety Labeling Changes for 41 drugs now available on web

The January 2008 posting includes 41 drug products with safety labeling changes to the following sections: BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, and PATIENT PACKAGE INSERTS, and MEDICATION GUIDES.

The Summary Page provides a listing of drug names and safety labeling sections revised: http://www.fda.gov/medwatch/SAFETY/2008/jan08_quickview.htm

The Detailed View Page identifies safety labeling sections and subsections revised along with a brief summary of new or modified safety information to the BOXED WARNING, CONTRAINDICATIONS, and/or WARNINGS sections: http://www.fda.gov/medwatch/SAFETY/2008/jan08.htm

In January 2008, the following drugs had modifications to the BOXED WARNING, CONTRAINDICATIONS, and/or WARNINGS sections:

EstroGel 0.06% (estradiol gel)

Herceptin (trastuzumab) Intravenous Infusion

Rituxan (rituximab) Injection For Intravenous Use

Alesse 28 Tablets (levonorgestrel and ethinyl estradiol tablets)

Janumet (sitagliptin/metformin HCl) Tablets

Mycamine (micafungin sodium) For Injection

Omnitrope [somatropin (rDNA origin) injection] For Subcutaneous Use

Tysabri (natalizumab) Injection For Intravenous Use

WelChol (colesevelam hydrochloride) Tablets

Azactam (aztreonam for injection, USP)

Azactam (aztreonam injection) in GALAXY Plastic Container (PL 2040) For Intravenous Use

Chantix (varenicline) Tablets

Cialis (tadalafil) Tablets

E.E.S. (erythromycin ethylsuccinate)

Ery-Ped (erythromycin ethylsuccinate, USP)

Humira (adalimumab) Injection, Solution For Subcutaneous Use

Lunesta (eszopiclone) Tablets

Ortho Evra (norelgestromin/ethinyl estradiol transdermal system)

PCE (erythromycin particles in tablets) Dispertab Tablets

Rapamune (sirolimus) Oral Solution and Tablets

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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