Update: 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 23 Apr 2008 06:00:17 -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: April 23, 2008 |
The following new items were added to the CDRH web pages on April 22, 2008. Previous CDRH New Items can be found on the CDRHNew Page.
 | Federal Register: Agency Information Collection Activites; Submission for Office of Management and Budget Review; Comment Request; Medical Devices; Device Tracking. |  |  |
Update: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 23 Apr 2008 08:24:39 -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.
Message: 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 23 Apr 2008 10:42:11 -0500 (CDT)
Subject: CDER New 4/22/2008
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April 22, 2008
- FDA approves Cimzia (certolizumab pegol) to treat Crohn's disease
- Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies (updated)
- New and Generic Drug Approvals
- Ciprofloxacin in Dextrose 5% in Plastic Container Injection, Hikma Farmaceutica, Approval
- Enablex (darifenacin hydrobromide) Extended Release Tablets, Novartis Pharma, Labeling Revision
- Hydrocodone Bitartrate and Acetaminophen Oral Solution, Pharmaceutical Assoc., Approval
- Singulair (montelukast sodium) Tablets, Merck & Co., Labeling Revision
- Singulair (montelukast sodium) Chewable Tablets, Merck & Co., Labeling Revision
- Singulair (montelukast sodium) Oral Granules, Merck & Co., Labeling Revision
- Tigan (trimethobenzamide hydrochloride) Intramuscular Injection, JHP Pharma, Labeling Revision
- Warning Letter: Peridex Zila Pharmaceuticals, Inc.
Update: 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 23 Apr 2008 11:07:41 -0500 (CDT)
Subject: FDA Clears Glove Made from New Type of Latex
FDA Clears Glove Made from New Type of Latex
Wed, 23 Apr 2008 11:15:00 -0500
The U.S. Food and Drug Administration has cleared for marketing the first device made from a new form of natural rubber latex, guayule latex. The product, the Yulex Patient Examination Glove, is derived from the guayule bush, a desert plant native to the Southwestern United States.
Update: 5
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 23 Apr 2008 16:05:54 -0500 (CDT)
Subject: DPH Issues Consumer Warning for Chang Farm Soy Sprouts Because of Bacteria Contamination (April 23)
DPH Issues Consumer Warning for Chang Farm Soy Sprouts Because of Bacteria Contamination (April 23)
Wed, 23 Apr 2008 16:44:00 -0500
The Department of Public Health (DPH) is issuing a warning to the public not to consume any soy sprouts produced from Chang Farms in Whatley, Massachusetts because of the presence of bacteria called Listeria monocytogenes (L. monocytogenes).
Update: 6
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 23 Apr 2008 18:05:43 -0500 (CDT)
Subject: FDA Strengthens Safeguards for Consumers of Beef
FDA Strengthens Safeguards for Consumers of Beef
Wed, 23 Apr 2008 17:08:00 -0500
The U.S. Food and Drug Administration today issued a final regulation barring certain cattle materials from all animal feed, including pet food. The final rule further protects animals and consumers against bovine spongiform encephalopathy (BSE, also known as "mad cow disease").
Update: 7
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 23 Apr 2008 19:10:35 -0500 (CDT)
Subject: Allergy Alert on Undeclared Dairy in 11-Ounce Single Serve Silk Soymilk Chocolate Flavor in Plastic Bottles (April 23)
Allergy Alert on Undeclared Dairy in 11-Ounce Single Serve Silk Soymilk Chocolate Flavor in Plastic Bottles (April 23)
Wed, 23 Apr 2008 18:35:00 -0500
WhiteWave Foods Company is voluntarily recalling 11-ounce plastic single serve bottles of Silk Soymilk Chocolate Flavor because it may contain undeclared milk protein.
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