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Drug Evaluation & Research

CDERNEW-TEXT 8/17/2007


Friday, August 17, 2007

FDA issues an FDA Alert, Public Health Advisory, and Information for
Healthcare Professional sheet on the use of codeine products in nursing
mothers. Drug Information
http://www.fda.gov/cder/drug/infopage/codeine/default.htm

FDA approves updated warfarin (marketed as Coumadin) prescribing
information. FDA News
http://www.fda.gov/bbs/topics/NEWS/2007/NEW01684.html

New and Generic Drug Approvals
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm

Hydrocodone Bitartrate and Acetaminophen Tablets, Ranbaxy Labs, Approval


Simvastatin Tablets, Dr. Reddy's Labs, Approval

Tegretol (carbamazepine) Tablets, Novartis Pharma, Labeling Revision

Tegretol (carbamazepine) Chewable Tablets, Novartis Pharma, Labeling
Revision

Tegretol (carbamazepine) Suspension, Novartis Pharma, Labeling Revision

Tegretol (carbamazepine) Extended-Release Tablets, Novartis Pharma,
Labeling Revision

Viramune (nevirapine) Tablets, Boehringer Ingelheim, Labeling Revision

Viramune (nevirapine) Oral Suspension, Boehringer Ingelheim, Labeling
Revision

Zingo (lidocaine hydrochloride monohydrate) Powder, Anesiva Inc.,
Approval


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posted by Mags @ 8:18 PM, ,




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posted by Mags @ 7:49 PM, ,