From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 20 May 2008 07:19:10 -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: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 20 May 2008 07:42:36 -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: May 20, 2008 |
The following new items were added to the CDRH web pages on May 19, 2008. Previous CDRH New Items can be found on the CDRHNew Page.
 | Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Plasmodium Species Antigen Detection Assays |  |  |
Updates: 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 20 May 2008 15:06:51 -0500 (CDT)
Subject: FDA Data Standards Update - SPL R4 Evaluation Materials
Greetings,
The FDA Data Standards Council's SPL web page was updated Tuesday, May 20, 2008, to post the SPL Release Four schema and a draft of the SPL Release Four stylesheet.
These documents are accessible via this hyperlink: http://www.fda.gov/oc/datacouncil/SPL_r4_registration_and_listing_material_v0.4.zip.
Lonnie Smith
Project Manager
Structured Product Labeling Team
FDA Data Standards Council
Updates: 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 20 May 2008 16:01:55 -0500 (CDT)
Subject: CDER New 5/20/2008
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May 20, 2008
- New and Generic Drug Approvals
- Acetaminophen, Caffeine and Dihydrocodeine Bitartrate Capsules, E5 Pharma, Inc., Manufacturing Revision
- Butorphanol Tartrate Preservative Free Injection, Apotex Corp., Control Supplement
- Emtriva (emtricitabine) Capsules, Gilead Sciences, Inc., Efficacy Supplement with Clinical Data to Support
- Emtriva (emtricitabine) Oral Solution, Gilead Sciences, Inc., Efficacy Supplement with Clinical Data to Support
- Norvir (ritonavir) Oral Solution, Abbott Laboratories, Labeling Revision
- Norvir (ritonavir) Capsules, Abbott Laboratories, Labeling Revision
- Tekturna (aliskiren hemifumarate) Tablets, Novartis Pharmaceuticals Corp., Labeling Revision
- Truvada (emtricitabine and tenofovir disoproxil fumarate) Tablets, Gilead Sciences, Inc., Efficacy Supplement with Clinical Data to Support
- Viread (tenofovir disoproxil fumarate) Tablets, Gilead Sciences, Inc., Efficacy Supplement with Clinical Data to Support
Updates: 5
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 20 May 2008 18:17:54 -0500 (CDT)
Subject: FDA Approves Entereg to Help Restore Bowel Function Following Surgery
FDA Approves Entereg to Help Restore Bowel Function Following Surgery
Tue, 20 May 2008 16:35:00 -0500
The U.S. Food and Drug Administration approved Entereg (alvimopan) today to accelerate the restoration of normal bowel function in patients 18 years and up who have undergone partial large or small bowel resection surgery. Entereg will be used in hospitalized patients who can receive no more than 15 doses.
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