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Guidance for Industry: New/Revised/Withdrawn List for 2007 [PDF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
------------------------------------------------
To subscribe or to unsubscribe from CDERNEW-TEXT
http://list.nih.gov/archives/cdernew-text.html
------------------------------------------------
posted by Mags @ 5:15 PM,
