From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 23 Jul 2008 08:00:50 -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: July 23, 2008 |
The following new items were added to the CDRH web pages on July 22, 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, Brief Summary, Transcript |  |
Update: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 23 Jul 2008 08:20:47 -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.
Update: 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 23 Jul 2008 11:23:50 -0500 (CDT)
Subject: CDER New 7/22/2008
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July 22, 2008
- Approved Drug Products List - Orange Book: FR Notice Determination of Safety or Effectiveness List
- Office of Generic Drugs: June First-Time Generic Drug Approvals
- Paragraph IV Patent Certifications (updated)
Update: 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 23 Jul 2008 18:14:42 -0500 (CDT)
Subject: CDER New 7/23/2008
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July 23, 2008
- Drugs@FDA Downloadable Data Files (updated)
- New and Generic Drug Approvals
- CANCIDAS (caspofungin acetate) Injection, Merck Research, Labeling Revision
- Kinlytic (urokinase) Injection, ImaRx Therapeutics, Labeling Revision
- Mirena (levonorgestrel) Intrauterine Releasing System, Bayer Healthcare, Labeling Revision
- Natacyn (natamycin) Ophthalmic Suspension, Alcon, Labeling Revision
- Tekturna HCT (aliskiren hemifumarate/hydrochlorothiazide) Tablets, Novartis Pharma, Labeling Revision
- ZIAGEN (abacavir sulfate) Tablets, GlaxoSmithKline, Efficacy Supplement with Clinical Data to Support
- ZIAGEN (abacavir sulfate) Oral Solution, GlaxoSmithKline, Efficacy Supplement with Clinical Data to Support
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