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,
,
CDERNEW-TEXT 11/5 & 6/2007
Tuesday, November 6, 2007
November 6, 2007
Drug Approval Reports http://www.fda.gov/cder/rdmt/default.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
New and Generic Drug Approvals
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm
Ampicillin Injection, Sandoz Inc., Microbiology
Ampicillin and Sulbactam Injection, Sandoz Inc., Microbiology
Ampicillin and Sulbactam Injection, Sandoz Inc., Microbiology
Ampicillin and Sulbactam Injection, Sandoz Inc., Microbiology
Baclofen 20mg Tablets, Actavis Totowa, Approval
Baclofen 10mg Tablets, Actavis Totowa, Approval
Benzonatate Capsules, KV Pharma, Approval
Ciprofloxacin Extended-release Tablets, Dr. Reddy's Labs, Approval
Lupron Depot (leuprolide acetate 3.75mg) Depot Suspension, Tap Pharma,
Labeling Revision
Lupron Depot (leuprolide acetate11.25mg) Depot Suspension, Tap Pharma,
Labeling Revision
Norvasc (amlodipine besylate) Tablets, Pfizer Inc., Labeling Revision
Prednisolone Sodium Phosphate Oral Solution, Vintage Pharma, Approval
Rivastigmine Tartrate Capsules, Dr. Reddy's Labs, Approval
SYMBICORT (budesonide/formoterol fumarate dihydrate) Inhalation Aerosol,
AstraZeneca Pharma, Labeling Revision
Vasotec (enalapril maleate)Tablets, Biovail Tech, Labeling Revision
Vaseretic (enalapril maleate/hydrochlorothiazide) Tablets, Biovail Tech,
Labeling Revision
November 5, 2007
FDA requests the marketing suspension of Trasylol (aprotinin)
http://www.fda.gov/bbs/topics/NEWS/2007/NEW01738.html
Guidance for Industry: Comprehensive List of Guidance Documents [PDF
http://www.fda.gov/cder/guidance/CompList11_2007.pdf ]
Guidance for Industry: New/Revised/Withdrawn List for 2007 [PDF
http://www.fda.gov/cder/guidance/newrevwithdrawn200710.pdf ]
New and Generic Drug Approvals
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm
Atenolol Tablets, Aurobindo Pharma, Approval
Carvedilol Tablets, Pliva Hrvatska, Approval
Dalmane (flurazepam hydrochloride) Capsules, Valeant Pharma, Labeling
Revision
Digoxin Tablets, West-ward Pharma, Approval
Doral (quazepam) Tablets, Questcor Pharma, Labeling Revision
Finasteride Tablets, Aurobindo Pharma, Approval
Kinlytic (Urokinase) Injection, ImaRx Therapeutics, Labeling Revision
PREVPAC (lansoprazole/amoxicillin/ clarithromycin), Tap Pharma, Labeling
Revision
Primacor (milrinone lactate) Injection, Sanofi-Aventis, Labeling
Revision
Primacor (milrinone lactate) in 5% Dextrose Injection, Sanofi-Aventis,
Labeling Revision
Saizen (somatropin [rDNA origin]) Injection, EMD Serono Inc., Package
Change
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posted by Mags @ 5:15 PM,
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