CDERNEW-TEXT 10/3 & 4/2007
Thursday, October 4, 2007
October 4, 2007
FDA announces the award of a contract to assist with the transformation
of FDA's Center for Drug Evaluation and Research
http://www.fda.gov/bbs/topics/NEWS/2007/NEW01718.html
New and Generic Drug Approvals
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm
Cordarone (amiodarone HCl) Tablets, Wyeth Pharma, Labeling Revision
Duetact (pioglitazone HCl plus glimepiride) Fixed-dose Combination
Tablets, Takeda Global, Formulation Revision
GEODON (ziprasidone HCl) Capsules, Pfizer Inc., Labeling Revision
GEODON (ziprasidone mesylate) Injection, Pfizer Inc., Labeling Revision
Linezolid Tablets, Teva Pharma, Tentative Approval
Metoprolol Tartrate Injection, Sandoz Pharma, Approval
NuvaRing (etonogestrel/ethinyl estradiol) Vaginal Ring, Organon Inc.,
Labeling Revision
Omnipaque (iohexol) Injection, GE Healthcare, Labeling Revision
October 3, 2007
Drugs@FDA Downloadable Data Files
http://www.fda.gov/cder/drugsatfda/datafiles/default.htm
(updated)
FDA acts to ensure that thyroid drugs don't lose their potency before
the expiration date. Levothyroxine Information
http://www.fda.gov/cder/drug/infopage/levothyroxine/default.htm
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posted by Mags @ 4:58 PM,
