CDERNEW-TEXT 8/30/2007
Thursday, August 30, 2007
August 30, 2007
New and Generic Drug Approvals
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm
Aloxi (palonosetron hydrochloride) Injection, Helsinn Healthcare, New
Dosage Regimen
Granisetron Hydrochloride Injection, Abraxis Pharma, Tentative Approval
Granisetron Hydrochloride Injection, Watson Labs, Tentative Approval
Serostim (somatropin [rDNA origin]) Injection, EMD Serono, Labeling
Revision
Office of Nonprescription Products: Rulemaking History for
Nonprescription Products
http://www.fda.gov/cder/otcmonographs/rulemaking_index.htm
(updated)
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posted by Mags @ 4:06 PM,
,
CDERNEW-TEXT 8/28 - 29/2007
Wednesday, August 29, 2007
August 29, 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)
New and Generic Drug Approvals
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm
Saizen (somatropin [rDNA origin]) Injection, EMD Serono, Labeling
Revision
Serostim (somatropin [rDNA origin]) Injection, EMD Serono, Labeling
Revision
Sumatriptan Succinate Tablets, Watson Labs, Tentative Approval
WelChol (colesevelam HCl) Tablets, Daiichi Sankyo, Labeling Revision
August 28, 2007
Office of Nonprescription Products: Rulemaking History for
Nonprescription Products
http://www.fda.gov/cder/otcmonographs/rulemaking_index.htm
(updated)
Guidance for Industry: Pharmacogenomic Data Submissions - Companion
Guidance http://www.fda.gov/cder/guidance/7735dft.pdf
PDF
http://www.fda.gov/graphics/pdf.gif
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posted by Mags @ 4:09 PM,
,
CDERNEW-TEXT 8/27/2007
Monday, August 27, 2007
August 27, 2007
Drug Master Files http://www.fda.gov/cder/dmf/index.htm
(updated)
Drug Shortage; Current; BiCNU
http://www.fda.gov/cder/drug/shortages/default.htm#Current
(updated)
International Conference on Harmonization (ICH) Public Meeting October
10, 2007, Rockville MD. Meeting information
http://www.fda.gov/cder/meeting/ICH_20071010.htm
New and Generic Drug Approvals
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm
Ammonia N 13 Injection, Feinstein Institute, Approval
Arthrotec (diclofenac sodium and misoprostol) Tablets, Pfizer, Inc.,
Labeling Revision
Carbidopa and Levodopa Extended Release Tablets, Sun Pharma, Approval
Carvedilol Tablets, Actavis Elizabeth, Tentative Approval
Carvedilol Tablets, Sandoz Inc., Tentative Approval
Clinoril (sulindac) Tablets, Merck & Co., Labeling Revision
Famciclovir Tablets, Teva Pharma, Approval
Glimepiride Tablets, Accord Healthcare, Approval
Quinapril Tablets, Invagen, Approval
Quinapril Hydrochloride Tablets, Teva Pharma, Approval
Quinapril Hydrochloride and Hydrochlorothiazide Tablets, Aurobindo
Pharma, Approval
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posted by Mags @ 4:24 PM,
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