Update: 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 19 Aug 2008 06:53:10 -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: August 19, 2008 |
The following new items were added to the CDRH web pages on August 18, 2008. Previous CDRH New Items can be found on the CDRHNew Page.
 | Ophthalmic Devices Panel Advisory Meeting, June 10, 2008 - Transcripts, Agenda, Minutes |  |
Update: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 19 Aug 2008 13:13:26 -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.
Recall: Antihemophilic Factor, Human - CSL Behring L.L.C.
Posted: 8/19/2008, Recall Date: 8/18/2008
Update: 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 19 Aug 2008 15:03:03 -0500 (CDT)
Subject: Drug Shortages: Current Drug Shortages; Methadone Hydrochloride Injection
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Drug Shortages: Current Drug Shortages; Methadone Hydrochloride Injection
Tue, 19 Aug 2008 14:10:00 -0500
See Web site for additional information on this current drug shortage
Update: 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 19 Aug 2008 15:03:03 -0500 (CDT)
Subject: Safety and Food Packaging
Safety and Food Packaging
Tue, 19 Aug 2008 14:55:00 -0500
FDA monitors all packaging that comes into contact with food. Here's an overview of how FDA conducts safety reviews of food contact substances.
Update: 5
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 19 Aug 2008 15:33:49 -0500 (CDT)
Subject: CDER New 8/18 - 19/2008
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August 19, 2008
- Drug Shortages: Current Drug Shortages; Methadone Hydrochloride Injection
- New and Generic Drug Approvals
- Children's Zyrtec Allergy (cetirizine hydrochloride) Syrup, McNeil-PPC, Inc., Formulation Revision
- Children's Zyrtec Allergy (cetirizine hydrochloride) Syrup, McNeil-PPC, Inc., Labeling Revision
- Children's Zyrtec Hives Relief (cetirizine hydrochloride) Syrup, McNeil-PPC, Inc., Formulation Revision
- Children's Zyrtec Hives Relief (cetirizine hydrochloride) Syrup, McNeil-PPC, Inc., Labeling Revision
- Haldol (haloperidol decanoate) Injection, Johnson & Johnson Pharmaceutical Research & Development, LLC, Labeling Revision
- Haldol (haloperidol lactate) Injection, Johnson & Johnson Pharmaceutical Research & Development, LLC, Labeling Revision
- Moban (molindone hydrochloride) Tablets, Endo Pharmaceuticals, Labeling Revision
- Megace ES (megestrol acetate) Oral Suspension, Par Pharmaceutical, Inc., Labeling Revision
- Thyrogen (thyrotropin alfa) Injection, Genzyme Corp., Labeling Revision
August 18, 2008
- FDA updates the Information for Healthcare Professionals sheet for Byetta (exenatide).
- Paragraph IV Patent Certifications (updated)
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