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

Update : 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 28 Aug 2008 09:01:47 -0500 (CDT)
Subject: CDRH New Update

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

Date: August 28, 2008

The following new items were added to the CDRH web pages on August 27, 2008. Previous CDRH New Items can be found on the CDRHNew Page.

Summary Information for: Attain StarFix Model 4195 Lead

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Update : 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 28 Aug 2008 10:18:27 -0500 (CDT)
Subject: CDER New 8/27/2008

August 27, 2008

• Drugs@FDA Downloadable Data Files (updated)
• Guidance for Industry: Integrated Summary of Effectiveness [PDF] or [HTML]
• New and Generic Drug Approvals
  • Omnitrope (somatropin [rDNA origin] Injection, Sandoz, Inc., Formulation Revision
  • Salonpas Patch (methyl salicylate and menthol), Hisamitsu Pharmaceutical Co., Inc., Package Change
  • Trandolapril Tablets, Dr. Reddy's Laboratories, Ltd., Approval

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Update : 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 28 Aug 2008 13:14:58 -0500 (CDT)
Subject: Pacific Consolidated Industries Oxygen Storage Tank Recall - Medical Device Safety

Pacific Consolidated Industries LLC has recalled the Mobile Oxygen Storage Tank due to the possibility that the pressure gauge may rupture and cause the tank to catch fire.

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Update : 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 28 Aug 2008 13:45:35 -0500 (CDT)
Subject: Medical Device Recalls: Pacific Consolidated Industries Mobile Oxygen Storage Tank

You are subscribed to Medical Device Recalls for U.S. Food & Drug Administration (FDA). Information about the Pacific Consolidated Industries LLC, Mobile Oxygen Storage Tank Class I Recall has recently been updated, and is now available.

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Update : 5
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 28 Aug 2008 17:02:50 -0500 (CDT)
Subject: Enforcement Report for August 27, 2008

Enforcement Report for August 27, 2008
Wed, 27 Aug 2008 11:30:00 -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: Thu, 28 Aug 2008 13:52:41 -0500 (CDT)
Subject: FDA MedWatch -Mobile Oxygen Storage Tank- Class I Recall Because The Device's Pressure Gauge May Rupture And May Catch Fire

Pacific Consolidated Industries, LLC, and FDA notified healthcare professionals of the Class I Recall of the Mobile Oxygen Storage Tank manufactured and distributed between January - March 2007, because the device's pressure gauge may rupture and may catch fire as a result of hydraulic fluid present in the pressure gauge tubing. The mobile oxygen storage tank is used in military aircraft for treating wounded patients and in disaster areas to quickly supply oxygen to patients. Facilities with the Mobile Oxygen Storage Tank should keep the device in quarantine until arrangements are made to ship the device back to the manufacturer.

Read the entire 2008 MedWatch Safety Summary, including a link to the FDA Recall Notice regarding this issue at:

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

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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

Food & Drug Administration (FDA) Daily Digest Bulletin

Update: 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 27 Aug 2008 07:41:40 -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.

Influenza Virus Vaccine 2008/2009 Season Lot Release Status - Update
Posted: 8/27/2008

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Update: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 27 Aug 2008 07:51:21 -0500 (CDT)
Subject: CDRH New Update

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

Date: August 27, 2008

The following new items were added to the CDRH web pages on August 26, 2008. Previous CDRH New Items can be found on the CDRHNew Page.

Summary Information for: T-SPOT-TB

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Update: 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 27 Aug 2008 08:18:50 -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, 27 Aug 2008 11:03:21 -0500 (CDT)
Subject: FDA Clears Test to Help Doctors Manage Heart Transplant Patients

FDA Clears Test to Help Doctors Manage Heart Transplant Patients
Wed, 27 Aug 2008 10:19:00 -0500

The U.S. Food and Drug Administration announced it has cleared for marketing a non-invasive test that uses molecular expression techniques to assist doctors in managing heart transplant patients post-surgery for potential organ rejection.

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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: Tue, 26 Aug 2008 07:03:47 -0500 (CDT)
Subject: CDER New 8/25/2008

August 25, 2008

• FDA updates the Information for Healthcare Professionals sheet for Tysabri (natalizumab).
• New and Generic Drug Approvals
  • Amicar (aminocaproic acid) Oral solution, Xanodyne Pharmaceuticals, Inc., Labeling Revision
  • Amicar (aminocaproic acid) Tablets, Xanodyne Pharmaceuticals, Inc., Labeling Revision
  • Ceftriaxone (ceftriaxone sodium) Injection, Bedford Laboratories, Approval
  • Losartan Potassium Tablets, Aurobindo Pharma, Ltd., Tentative Approval
  • Metaglip (glipizide and metformin hydrochloride) Tablets, Bristol-Myers Squibb Co., Labeling Revision
  • Mucinex (guaifenesin) Extended-Release Tablets, Adams Respiratory Therapeutics, Package Change
  • Pamidronate Disodium Injection, Pliva-Lachema, AS, Approval
  • Qvar 40 (beclomethasone dipropionate) Inhalation Aerosol, Teva Global Regulatory Research, LLC, Labeling Revision
  • Qvar 80 (beclomethasone dipropionate) Inhalation Aerosol, Teva Global Regulatory Research, LLC, Labeling Revision
  • Rocephin (ceftriaxone sodium) Injection, HLR Technology Corp., Labeling Revision
  • Rocephin Kit (ceftriaxone sodium and lidocaine) Injection, HLR Technology Corp., Labeling Revision
  • Somavert (pegvisomant) Injection, Pharmacia & Upjohn, Labeling Revision
  • Sustiva (efavirenz) Capsules, Bristol-Myers Squibb Co., Labeling Revision
  • Sustiva (efavirenz) Tablets, Bristol-Myers Squibb Co., Labeling Revision
  • Vidaza (azacitidine) Subcutaneous I.V. Injection, Celgene Corp., Efficacy Supplement with Clinical Data to Support

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Update: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 26 Aug 2008 07:48:08 -0500 (CDT)
Subject: CDRH New Update

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

Date: August 26, 2008

The following new items were added to the CDRH web pages on August 25, 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; Certification to Accompany Drug, Biological Product, and Device Applications or Submissions (Form FDA 3674)
	Federal Register: FDA Regulations; Technical Amendment
	PMA Final Decisions for July 2008

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Update: 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 26 Aug 2008 08:28:40 -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: FDA Regulations; Technical Amendment; Final Rule - 8/25/2008

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Update: 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 26 Aug 2008 08:48:44 -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.

FEDERAL REGISTER: FDA Regulations; Technical Amendment; Final Rule
Posted: 8/26/2008

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Update: 5
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 26 Aug 2008 11:03:12 -0500 (CDT)
Subject: Drug Shortages: Current Drug Shortages; Zanosar (Streptozocin) Injection

Drug Shortages: Current Drug Shortages; Zanosar (Streptozocin) Injection
Tue, 26 Aug 2008 11:00:00 -0500

See Web site for additional information on this current drug shortage

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Update: 6
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 26 Aug 2008 17:25:07 -0500 (CDT)
Subject: CDER New 8/26/2008

August 26, 2008

• Drug Shortages: Current Drug Shortages; Zanosar (Streptozocin) Injection
• New and Generic Drug Approvals
  • Aloxi (palonosetron hydrochloride) Capsules, Helsinn Healthcare, SA, Approval
  • Monistat 7 (miconazole nitrate) Vaginal Cream, Johnson & Johnson Healthcare Products, Manufacturing Change or Addition
  • Precose (acarbose) Tablets, Bayer HealthCare Pharmaceuticals, Labeling Revision

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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