From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 24 Jun 2008 07:46:36 -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: June 24, 2008 |
The following new items were added to the CDRH web pages on June 23, 2008. Previous CDRH New Items can be found on the CDRHNew Page.
 | PMA Final Decisions for May 2008 |  |
Update : 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 24 Jun 2008 08:36:47 -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.
Update : 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 24 Jun 2008 11:43:23 -0500 (CDT)
Subject: U.S. Food & Drug Administration (FDA) CBER's Recalls, Withdrawals, Field Corrections & Notifications Update
You are subscribed to CBER's Recalls, Withdrawals, Field Corrections & Notifications for U.S. Food & Drug Administration (FDA). This information has recently been updated, and is now available.
Correction of AUSZYME Monoclonal Assay - Abbott Laboratories
Posted: 6/24/2008; Correction Date: 6/12/2008
Update : 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 24 Jun 2008 17:26:40 -0500 (CDT)
Subject: CDER New 6/23 & 24/2008
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June 24, 2008
- FDA/Consumer Healthcare Products Association Workshop: Current Good Manufacturing Practices (CGMP) 2008. August 4, 2008, Chicago, Illinois. Meeting information and registration
- New and Generic Drug Approvals
- Cetirizine Hydrochloride Syrup, Taro Pharmaceutical Industries, Ltd., Approval
- Doryx (doxycycline hyclate) Delayed-Release Tablets, Warner Chilcott (U.S.), Inc., Formulation Revision
- Durezol (difluprednate) Ophthalmic Emulsion, Sirion Therapeutics, Inc., Approval
- Kuvan (sapropterin dihydrochloride) Tablets, BioMarin Pharmaceuticals, Inc., Package Change
- Micronor (norethindrone) Tablets, Ortho McNeil Pharmaceutical, Inc., Labeling Revision
- Ramipril Capsules, Dr. Reddy's Labs, Ltd., Approval
- Ramipril Capsules, Apotex Corp., Approval
- Rowasa (mesalamine) Enema, Alaven Pharmaceutical, LLC, Formulation Revision
- Valganciclovir Hydrochloride Tablets, Ranbaxy, Inc., Tentative Approval
- Velcade (bortezomib) Intravenous Injection, Millennium Pharmaceuticals, Inc., New or Modified Indication
- Zaleplon Capsules, Cipla, Ltd., Approval
- Zyvox (linezolid) Tablets, Pharmacia & Upjohn, Labeling Revision
- Zyvox (linezolid) IV Injection, Pharmacia & Upjohn, Labeling Revision
- Zyvox (linezolid) Oral Suspension, Pharmacia & Upjohn, Labeling Revision
June 23, 2008
- Paragraph IV Patent Certifications (updated)
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