Thursday, August 28, 2008

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

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Center for Drug Evaluation and Research, U.S. Food and Drug Administration
HHS Logo links to Department of Health and Human Services website

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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

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

Skip NavigationFDA Logo links to FDA home pageCenter for Devices and Radiological Health, U.S. Food and Drug AdministrationHHS Logo links to Department of Health and Human Services website
FDA Home Page | CDRH Home Page | Search | A-Z Index U.S. Food and Drug AdministrationCenter for Devices and Radiological Health Questions?
horizonal rule
CDRHNEW Logo 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) Text PDF
* Federal Register: FDA Regulations; Technical Amendment Text PDF
* PMA Final Decisions for July 2008 Text

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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

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

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

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Center for Drug Evaluation and Research, U.S. Food and Drug Administration
HHS Logo links to Department of Health and Human Services website

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

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

FDA Logo links to FDA home page
Center for Drug Evaluation and Research, U.S. Food and Drug Administration
HHS Logo links to Department of Health and Human Services website

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August 26, 2008

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