CDERNEW-TEXT 10/24/2007
Thursday, October 25, 2007
October 24, 2007
CDER Organization Charts [HTML http://www.fda.gov/cder/cderorg.htm ]
[PDF http://www.fda.gov/cder/cderorg/cder-all.pdf ] (updated)
Drugs@FDA Downloadable Data Files
http://www.fda.gov/cder/drugsatfda/datafiles/default.htm
(updated)
FDA and Cephalon notify healthcare professionals of updates to the
Warnings section of the prescribing information for Provigil (modafinil)
http://www.fda.gov/medwatch/safety/2007/safety07.htm#Provigil
Guidance for Industry: Drug-Induced Liver Injury: Premarketing Clinical
Evaluation [PDF http://www.fda.gov/cder/guidance/7507dft.pdf ] or [HTML
http://www.fda.gov/cder/guidance/7507dft.htm ]
Warning Letter: BMIS Inspection (Warning Letter) Sanofi-Aventis U.S.
http://www.fda.gov/cder/warn/warn2007.htm#October
------------------------------------------------
To subscribe or to unsubscribe from CDERNEW-TEXT
http://list.nih.gov/archives/cdernew-text.html
------------------------------------------------
posted by Mags @ 6:38 AM,
,
CDERNEW-TEXT 10/22 & 23/2007
Tuesday, October 23, 2007
October 23, 2007
New and Generic Drug Approvals
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm
Coreg CR (carvedilol phosphate) Extended-release Capsules, SB Pharmco,
Labeling Revision
Granisetron Hydrochloride Injection, Teva Parenteral, Tentative
Approval
Granisetron Hydrochloride Tablet, Cipla Ltd., Tentative Approval
Glyburide Tablets, Aurobindo Pharma, Approval
LEVITRA (vardenafil hydrochloride) Tablets, Bayer Pharma, Labeling
Revision
Repraxain (Hydrocodone Bitartrate and Ibuprofen) Tablets, Interpharm
Inc., New Strength & Labeling
SORIATANE (acitretin) Capsules, Stiefel Labs, Labeling Revision
October 22, 2007
FDA approves Ixempra (ixabepilone) for advanced breast cancer patients
http://www.fda.gov/bbs/topics/NEWS/2007/NEW01732.html .
New and Generic Drug Approvals
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm
CIALIS (tadalafil) Tablets, Lilly Icos Inc., Labeling Revision
Colgate Total Toothpaste (sodium fluoride and triclosan dentifrice),
Colgate-Palmolive, Formulation Revision
Escitalopram Oxalate Tablets, Sandoz, Tentative Approval
Granisetron Hydrochloride Injection, Baxter Healthcare, Tentative
Approval
Ketoconazole Shampoo, Tolmar Inc., Formulation Revision
Losartan Potassium and Hydrochlorothiazide Tablets, TEVA Pharma,
Tentative Approval
Rapamune (sirolimus) Oral Solution, Wyeth Pharma, Labeling Revision
Rapamune (sirolimus) Tablets, Wyeth Pharma, Labeling Revision
Torsemide Tablets, Aurobindo Pharma, Approval
Vexol (rimexolone ophthalmic suspension), Alcon Labs, Labeling Revision
VIAGRA (sildenafil citrate) Tablets, Pfizer Inc., Labeling Revision
Voltaren Gel (diclofenac sodium) Topical Gel, Novartis, Approval
------------------------------------------------
To subscribe or to unsubscribe from CDERNEW-TEXT
http://list.nih.gov/archives/cdernew-text.html
------------------------------------------------
posted by Mags @ 4:38 PM,
,