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,
