CDERNEW-TEXT 11/7 - 9/2007
Friday, November 9, 2007
November 9, 2007
Approved Drug Products with Therapeutic Equivalence Evaluations Orange
Book http://www.fda.gov/cder/orange/default.htm
Drug Shortage
Drug to be Discontinued; Procanbid (Procanamide Hydrochloride
Extended-Release Tablets)
http://www.fda.gov/cder/drug/shortages/default.htm#Procanbid
New and Generic Drug Approvals
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm
Brevibloc (esmolol hydrochloride) IV, Baxter Healthcare, Labeling
Revision
LOVAZA (omega-3-acid ethyl esters) Capsules, Reliant Pharma, Labeling
Revision
PEPCID (famotidine) Oral Suspension, Salix Pharma, Labeling Revision
PEPCID (famotidine) Tablets, Merck & Co., Labeling Revision
PEPCID (famotidine) Injection , Merck & Co., Labeling Revision
PEPCID (famotidine) Injection Premixed, Merck & Co., Labeling Revision
November 8, 2007
Drug Approval Reports http://www.fda.gov/cder/rdmt/default.htm
Fast Track Fiscal Year 2007
http://www.fda.gov/cder/rdmt/INTERNETFTSTATS.HTM
Fast Track Designation (FY 1998 - FY 2006)
http://www.fda.gov/cder/rdmt/internetftstat_FY98-06.HTM
NDA and BLA Approvals http://www.fda.gov/cder/rdmt/InternetNDA07.htm
NME Drug and New Biologic Approvals
http://www.fda.gov/cder/rdmt/InternetNME07.htm
Priority NDA and BLA Approvals
http://www.fda.gov/cder/rdmt/InternetPriority07.htm
FDA strengthens the Boxed Warnings and approves other safety labeling
changes for erythropoiesis-stimulating agents (ESAs). [FDA News
http://www.fda.gov/bbs/topics/NEWS/2007/NEW01740.html ]; [Public Health
Advisory] http://www.fda.gov/cder/drug/advisory/RHE200711.htm ;
[Information for Healthcare Professionals]
http://www.fda.gov/cder/drug/InfoSheets/HCP/RHE200711HCP.htm
Guidance for Industry: Chronic Obstructive Pulmonary Disease: Developing
Drugs for Treatment [PDF http://www.fda.gov/cder/guidance/7875dft.pdf ]
or [HTML http://www.fda.gov/cder/guidance/7875dft.htm ]
New and Generic Drug Approvals
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm
CELEBREX (celecoxib) Capsules, G.D. Searle, Labeling Revision
Colazal (balsalazide disodium) Capsules, Salix Pharma, Labeling Revision
Fever All (acetaminophen) Rectal Suppositories, Actavis, Manufacturing
Change or Addition
Inderal LA Capsules, Wyeth Pharma, Labeling Revision
Lamivudine/Stavudine Tablets, Matrix Labs, Tentative Approval
Lovastatin Tablets, Lupin Ltd., Approval
Myfortic (mycophenolic acid) Delayed-Release Tablets, Novartis Pharma,
Labeling Revision
Sterile Water Injection, Hospira Inc., Package Change
Zometa (zoledronic acid) Injection, Novartis Pharma, Labeling Revision
November 7, 2007
Adolescent Over-the-Counter (OTC) Drug Product Use: A Public Workshop,
December 6 and 7, 2007
http://www.fda.gov/cder/meeting/adolescent_OTC.htm
Drug Firm Annual Registration Status
http://www.fda.gov/cder/dfars/default.htm
Drugs@FDA Downloadable Data Files
http://www.fda.gov/cder/drugsatfda/datafiles/default.htm
(updated)
National Drug Code Directory Search
http://www.fda.gov/cder/ndc/database/default.htm
National Drug Code Directory Download
http://www.fda.gov/cder/ndc/index.htm
Notice of Violation: Natrecor (nesiritide) for injection
http://www.fda.gov/cder/warn/warn2007.htm#November
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posted by Mags @ 5:41 PM,
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