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: 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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