Thursday, July 24, 2008

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

Update : 1

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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CDRHNEW Logo 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 Text

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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

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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Center for Drug Evaluation and Research, U.S. Food and Drug Administration
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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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