From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 11 Jun 2008 07:48:02 -0500 (CDT)
Subject: CDRH New Update
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| FDA Home Page | CDRH Home Page | Search | A-Z Index |  | |
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 | Date: June 11, 2008 |
The following new items were added to the CDRH web pages on June 10, 2008. Previous CDRH New Items can be found on the CDRHNew Page.
 | Anesthesiology and Respiratory Therapy Devices Panel Advisory Meeting, June 12, 2008 - Agenda, Roster, Briefing, Questions |  |
| Consumer Information on: ELA Ovatio CRT-D System - P060027 | |
| Consumer Information on: Talent™ Thoracic Stent Graft System - P070007 | |
Updates: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 11 Jun 2008 08:19:38 -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.
Updates: 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 11 Jun 2008 09:00:13 -0500 (CDT)
Subject: Recent Device Approvals: Medtronic Talent™ Thoracic Stent Graft System
You are subscribed to Recent Device Approvals updates for U.S. Food & Drug Administration (FDA). Information about Medtronic's Talent™ Thoracic Stent Graft System has recently been posted to the FDA website, and is now available.
Updates: 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 11 Jun 2008 10:17:26 -0500 (CDT)
Subject: CDER New 6/10/2008
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June 10, 2008
- Manual of Policies and Procedures (MaPP) 4657.1R Alternate Work Schedules (AWS)
- Guidance for Industry: Updating Labeling for Susceptibility Test Information in Systemic Antibacterial Drug Products and Antimicrobial Susceptibility Testing Devices [PDF]
- New and Generic Drug Approvals
- Atripla (efavirenz, emtricitabine and tenofovir disoproxil fumarate) Tablets, Gilead Sciences, Inc., Efficacy Supplement with Clinical Data to Support
- Flector (diclofenac epolamine) Patch, Institute Biochimique SA (IBSA), Labeling Revision
- Naloxone Hydrochloride Injection, International Medication Systems, Ltd., Facility Addition
- Optison (albumin human) Injection, GE Healthcare, Labeling Revision
- Zaleplon Capsules, Roxane Laboratories, Inc., Approval
- Zaleplon Capsules, Genpharm ULC, Approval
- Zaleplon Capsules, Sandoz, Inc., Approval
- Zaleplon Capsules, Upsher-Smith Laboratories, Inc., Approval
- Zaleplon Capsules, Aurobindo Pharma USA, Inc., Approval
- Zaleplon Capsules, Unichem Pharmaceuticals USA, Inc., Approval
- Zaleplon Capsules, Teva Pharmaceuticals USA, Approval
- Zetia (ezetimibe) Tablets, MSP Singapore Co., LLC, Labeling Revision
- Zetia (ezetimibe) Tablets, MSP Singapore Co., LLC, Patient Population Altered
Updates: 5
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 11 Jun 2008 14:10:43 -0500 (CDT)
Subject: U.S. Food & Drug Administration (FDA) CBER's Guidances Update
You are subscribed to CBER's Guidances for U.S. Food & Drug Administration (FDA). This information has recently been updated, and is now available.
Updates: 6
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 11 Jun 2008 17:04:10 -0500 (CDT)
Subject: Warning for Regranex--Cream for Leg and Foot Ulcers
Warning for Regranex--Cream for Leg and Foot Ulcers
Wed, 11 Jun 2008 16:12:00 -0500
A boxed warning has been added to the label of Regranex Gel 0.01% (becaplermin) to address the increased risk of cancer death in patients who use three or more tubes of the product.
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