Update : 1
Subject: CDRH New Update
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| FDA Home Page CDRH Home Page Search A-Z Index |  | |
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 | Date: March 20, 2008 |
The following new items were added to the CDRH web pages on March 19, 2008. Previous CDRH New Items can be found on the CDRHNew Page.
 | PMA Final Decisions for February 2008 |  |
Update : 2
Subject: Acme Issues Voluntary Recall for Acme Labeled Cinnamon Rolls with Icing (March 18)
Acme Issues Voluntary Recall for Acme Labeled Cinnamon Rolls with Icing (March 18)
Thu, 20 Mar 2008 06:38:00 -0500
Acme Markets is issuing a voluntary recall on all codes of Acme label 4-pack cinnamon rolls with icing due to the undeclared milk ingredient. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume this product. The recall affects all Acme locations in New Jersey, Pennsylvania, Delaware and Maryland.
Update : 3
Subject: FDA Data Standards Update - FDA Data Standards Update - SPL Terminology Update
Greetings,
The FDA Data Standards Council's SPL web page was updated Thursday, March 20, 2008, to include an additional FDA preferred term and NCI Concept Code under Business Operations:
United States Agent - C73330
The new term and code are located on this web page: http://www.fda.gov/oc/datacouncil/term.html#busop.
Lonnie Smith
Project Manager
Food and Drug Administration
Update : 4
Subject: CDER New March 19
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March 19, 2008
- http://www.fda.gov/cder/drugsatfda/datafiles/default.htm (updated)
- New and Generic Drug Approvals
- Benzonatate Capsules, Sun Pharmaceutical Industries, Inc., Approval
- Ciprofloxacin in Dextrose 5% in Plastic Container Injection, Baxter Healthcare, Inc., Approval
- Ciprofloxacin in Dextrose 5% in Plastic Container Injection, Bedford Inc., Approval
- Ciprofloxacin in Dextrose 5% in Plastic Container Injection, Claris Lifesciences Ltd., Approval
- Ciprofloxacin in Dextrose 5% in Plastic Container Injection, Hospira Inc., Approval
- Ciprofloxacin in Dextrose 5% in Plastic Container Injection, Sagent Pharmaceuticals, Approval
- Ciprofloxacin in Dextrose 5% in Plastic Container Injection, Teva Parenteral Medicines, Inc, Approval
- Divalproex Sodium Delayed Release Tablets, Zydus Pharmaceuticals, Tentative Approval
- Fosphenytoin Sodium Injection, Akorn-Strides, LLC, Approval
- Fosphenytoin Sodium Injection, Sun Pharmaceutical Industries, Inc., Approval
- Rizatriptan Benzoate Orally Disintegrating Tablets, Mylan Pharmaceuticals, Tentative Approval
- Symbyax (fluoxetine hydrochloride; olanzapine) Capsules, Eli Lilly and Co., Labeling Revision
Update : 5
Subject: CDER New March 20
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March 20, 2008
New and Generic Drug Approvals- Cefepime Hydochloride Injection, ACS Dobfar, Approval
- Levitra (vardenafil hydrochloride) Tablets, Bayer Healthcare, Inc., Labeling Revision
- TREANDA (bendamustine hydrochloride) Injection, Cephalon, Approval
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