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: Mon, 23 Jun 2008 06:00:46 -0500 (CDT)
Subject: CDRH New Update

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

Date: June 23, 2008

The following new items were added to the CDRH web pages on June 20, 2008. Previous CDRH New Items can be found on the CDRHNew Page.

Office of Device Evaluation (ODE) Fiscal Year 2006 and Fiscal Year 2007 Annual Report

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Message: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 23 Jun 2008 17:03:36 -0500 (CDT)
Subject: Fresca Italia, Inc., Expands Recall of Burrata Cheese Because of Possible Health Risk (June 23)

Fresca Italia, Inc., Expands Recall of Burrata Cheese Because of Possible Health Risk (June 23)
Mon, 23 Jun 2008 16:23:00 -0500

Fresca Italia is recalling Burrata, a type of cheese, because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as fever, headache, stiffness, nausea, abdominal, or diarrhea, listeria infection can cause miscarriages and stillbirths among pregnant women.

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Message: 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 23 Jun 2008 12:37:28 -0500 (CDT)
Subject: FDA MedWatch - February 2008 Drug Safety Labeling Changes for 47 drugs now available on web

The February 2008 posting includes 47 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/feb08_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/feb08.htm

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

Atripla (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) Tablets

Cleocin Sterile Solution (clindamycin injection)

Cleocin Phosphate (clindamycin injection in 5% dextrose) IV Sterile Solution

Duragesic (fentanyl) Transdermal System

Emsam (selegiline transdermal system) Patches

Fentora (fentanyl buccal tablet)

Lincocin (lincomycin) Injection

Asmanex Twisthaler (mometasone furoate inhalation powder)

Abilify (aripiprazole) Tablets and Oral Solution

Abilify (aripiprazole) Discmelt Orally Disintegrating Tablets

Abilify (aripiprazole) Injection for Intramuscular Use Only

Avastin (bevacizumab) for Intravenous Use

Claforan Sterile (cefotaxime sodium for injection, USP) and Injection (cefotaxime sodium injection, USP)

Cortenema (hydrocortisone retention enema)

Doryx (doxycycline hyclate) Capsule, Delayed Release Pellets

Eryc (erythromycin delayed-release capsules, USP)

Erythrocin Lactobinate (erythromycin lactobionate) Injection, Powder, Lyophilized, For Solution

Geocillin (carbenicillin indanyl sodium) Tablets

Halcion (triazolam tablets)

Janumet (sitagliptin/metformin HCl) Tablets

Letairis (ambrisentan) Tablets

Premarin Intravenous (conjugated estrogens, USP) for injection

Remodulin (treprostinil sodium) Injection

Restoril (temazepam) Capsules

Reyataz (atazanavir sulfate) Capsules 

Sensipar (cinacalcet) Tablets

Ultram ER (tramadol HCl) Extended-Release Tablets

Vibramycin Calcium (doxycycline calcium oral suspension, USP) Oral Suspension Syrup

Vibramycin Hyclate (doxycycline hyclate capsules, USP) Capsules

Vibramycin Monohydrate (doxycycline monohydrate) for Oral Suspension

Vibra-Tabs (doxycycline hyclate tablets, USP) Film Coated 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

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: Fri, 20 Jun 2008 05:34:29 -0500 (CDT)
Subject: CDRH New Update

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

Date: June 20, 2008

The following new items were added to the CDRH web pages on June 19, 2008. Previous CDRH New Items can be found on the CDRHNew Page.

	Federal Register: Medical Devices; Technical Amendment.
	Ophthalmic Devices Panel Advisory Meeting, June 10, 2008 - Slides

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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, 19 Jun 2008 16:05:07 -0500 (CDT)
Subject: FDA Requests Seizure of Animal Food Products at PETCO Distribution Center

FDA Requests Seizure of Animal Food Products at PETCO Distribution Center
Thu, 19 Jun 2008 15:23:00 -0500

At the request of the U.S. Food and Drug Administration (FDA), U.S. Marshals seized various animal food products stored under unsanitary conditions at the PETCO Animal Supplies Distribution Center located in Joliet, Ill., pursuant to a warrant issued by the United States District Court in Chicago.

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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: Wed, 18 Jun 2008 06:28:56 -0500 (CDT)
Subject: CDRH New Update

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

Date: June 18, 2008

The following new items were added to the CDRH web pages on June 17, 2008. Previous CDRH New Items can be found on the CDRHNew Page.

Office of Science and Engineering Laboratories (OSEL) Fiscal Year 2007 Annual Report

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Message: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 18 Jun 2008 09:06:56 -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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Message: 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 18 Jun 2008 10:04:57 -0500 (CDT)
Subject: FDA Approves Diaphragm-Pacing Device

FDA Approves Diaphragm-Pacing Device
Wed, 18 Jun 2008 09:17:00 -0500

The U.S. Food and Drug Administration today announced that it approved the NeuRx DPS RA/4 Respiratory Stimulation System, an implantable electronic device that stimulates the diaphragm and allows certain spinal cord injury patients to breathe for at least four hours a day without a mechanical ventilator.

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Message: 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 18 Jun 2008 12:05:01 -0500 (CDT)
Subject: United States and China Outline Progress on Agreement on Food and Feed Safety (HHS Release)

United States and China Outline Progress on Agreement on Food and Feed Safety (HHS Release)
Wed, 18 Jun 2008 11:28:00 -0500

U.S. Secretary of Health and Human Services (HHS) Mike Leavitt signed a Joint Progress Statement today with the Honorable Li Changjiang, Minister of the General Administration of Quality Supervision, Inspection, and Quarantine (AQSIQ) of the People’s Republic of China. The document outlines steps taken by both nations in implementing the 2007 Memorandum of Agreement (MOA) on food and feed safety.

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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: Tue, 17 Jun 2008 10:05:46 -0500 (CDT)
Subject: FDA Warns Individuals and Firms to Stop Selling Fake Cancer 'Cures'

FDA Warns Individuals and Firms to Stop Selling Fake Cancer 'Cures'
Tue, 17 Jun 2008 09:30:00 -0500

Warning Letters have been sent to 23 U.S. companies and two foreign individuals marketing a wide range of products fraudulently claiming to prevent and cure cancer, according to the U.S. Food and Drug Administration today. The FDA also warns North American consumers against using or purchasing the products, which include tablets, teas, tonics, black salves, and creams, and are sold under various names on the Internet.

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Message: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 17 Jun 2008 12:49:20 -0500 (CDT)
Subject: Recent Device Approvals: Biotronik Left Ventricular Pacing Leads

You are subscribed to Recent Device Approvals updates for U.S. Food & Drug Administration (FDA). Information about Biotronik's Stratos LV and Stratos LV T CRT Ps and Corox OTW BP and Corox OTW S BP Left Ventricular Pacing Leads has recently been posted to the FDA website, and is now available.

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Message: 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 17 Jun 2008 19:03:58 -0500 (CDT)
Subject: Tipu's Tiger Chai, Inc Recalls Tipus Tiger Chai Concentrate Because of a Possible Health Risk (June 17)

Tipu's Tiger Chai, Inc Recalls Tipus Tiger Chai Concentrate Because of a Possible Health Risk (June 17)
Tue, 17 Jun 2008 18:48:00 -0500

Tipu's Tiger Chai Inc, of Missoula, Montana is voluntarily recalling its Tipu's Tiger Chai Concentrate because it has the potential to be contaminated with Clostridium botulinum, a bacterium which can cause life-threatening illness or death. Consumers are warned not to use the product even if it does not look or smell spoiled.

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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