CDERNEW-TEXT 11/13/2007
Tuesday, November 13, 2007
November 13, 2007
Drug Approval Reports: Efficacy Supplement Approvals
http://www.fda.gov/cder/rdmt/ESCY07AP.htm
New and Generic Drug Approvals
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm
Arava (leflunomide) Tablets, Sanofi-Aventis, Labeling Revision
Crestor (rosuvastatin calcium) Tablets, IPR Pharma, New or Modified
Indication
ELIGARD (leuprolide acetate 45mg) for Injectable Suspension,
Sanofi-Aventis, Labeling Revision
ELIGARD (leuprolide acetate 30mg) for Injectable Suspension,
Sanofi-Aventis, Labeling Revision
ELIGARD (leuprolide acetate 22.5mg) for Injectable Suspension,
Sanofi-Aventis, Labeling Revision
ELIGARD (leuprolide acetate 7.5mg) for Injectable Suspension,
Sanofi-Aventis, Labeling Revision
Lamotrigine Tablets, Sandoz Inc., Tentative Approval
Optison (Perflutren Protein-Type A Micropheres) Injection, GE
Healthcare, Labeling Revision
SPRYCEL (dasatinib) Tablets, Bristol-Myers Squibb, New Dosage Regimen &
Efficacy Supp. w/Clinical Data
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posted by Mags @ 5:30 PM,
,
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,
,
CDERNEW-TEXT 11/1/2007
Thursday, November 1, 2007
November 1, 2007
New and Generic Drug Approvals
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm
Adagen (pegademase bovine) Injection, Enzon Pharma, Labeling Revision
Bethanechol Chloride 5mg Tablets, Pharmax Group, Approval
Bethanechol Chloride 10mg Tablets, Pharmax Group, Approval
Bethanechol Chloride 25mg Tablets, Pharmax Group, Approval
Bethanechol Chloride 50mg Tablets, Pharmax Group, Approval
DDAVP Intranasal (desmopressin acetate), Sanofi-Aventis, Labeling
Revision
DDAVP Injection (desmopressin acetate) , Sanofi-Aventis, Labeling
Revision
DDAVP Tablets (desmopressin acetate) , Sanofi-Aventis, Labeling Revision
Tri-Legest-21 (Norethindrone Acetate and Ethinyl Estradiol) Tablets,
Barr Labs, Approval
Visken (pindolol) Tablets, Novartis Pharma, Labeling Revision
VIVITROL (naltrexone) Extended-release Injectable Suspension, Alkermes
Inc., Labeling Revision
Warning Letter: Site Inspection - Northeast General Pharmaceutical
Factory http://www.fda.gov/cder/warn/warn2007.htm#October
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posted by Mags @ 5:01 PM,
,
CDERNEW-TEXT 10/31/2007
October 31, 2007
Drugs@FDA Downloadable Data Files
http://www.fda.gov/cder/drugsatfda/datafiles/default.htm
(updated)
FDA approves Tasigna (nilotinib) for the treatment of Philadelphia
chromosome positive chronic myeloid leukemia
http://www.fda.gov/bbs/topics/NEWS/2007/NEW01734.html .
New and Generic Drug Approvals
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm
Baclofen 10mg Tablets, Impax Labs, Approval
Baclofen 20mg Tablets, Impax Labs, Approval
Cetirizine Hydrochloride Syrup, Taro Pharma, Tentative Approval
Cetirizine Hydrochloride Tablets, Cipla Ltd., Tentative Approval
Fenofibrate Tablets, Par Pharma, Control Suppl.
Levocarnitine Oral Solution, P3 Labs, Approval
Symbicort (budesonide/formoterol fumarate dihydrate) Inhalation Aerosol,
Astra Zeneca, Control Supp.
Requesting a Pre-Assigned Electronic Common Technical Document (eCTD)
Number from Office of Generic Drugs
http://www.fda.gov/cder/ogd/request_preassigned_ectd.htm
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posted by Mags @ 11:23 AM,
,
CDERNEW-TEXT 10/29 & 30/2007
Wednesday, October 31, 2007
October 30, 2007
Guidance for Industry: Role of HIV Resistance Testing in Antiretroviral
Drug Development [PDF http://www.fda.gov/cder/guidance/7688fnl.pdf ]
Postmarketing Study Commitments Search
http://www.accessdata.fda.gov/scripts/cder/pmc/index.cfm
(updated)
October 29, 2007
CellCept (mycophenolate mofetil)
http://www.fda.gov/medwatch/safety/2007/safety07.htm#CellCept2 - Changes
to prescribing information due to increased risk of first trimester
pregnancy loss and increased risk of congenital malformations.
Guidance for Industry: Acute Bacterial Sinusitis: Developing Drugs for
Treatment [PDF http://www.fda.gov/cder/guidance/3895dft.pdf ]
New and Generic Drug Approvals
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm
Epirubicin Hydrochloride Injection, Watson Labs, Approval
Omeprazole Delayed-release Capsules 10 & 20mg, Apotex, Approval
Omeprazole Delayed-release Capsules 10 & 20mg, Impax Labs, Approval
Omeprazole Delayed-release Capsules 10 & 20mg, Dr. Reddy's Labs,
Approval
Renagel (sevelamer hydrochloride) Tablets, Genzyme Corp., Efficacy Supp.
w/Clinical Data
Renvela (sevelamer carbonate) Tablets, Genzyme Corp., Approval
Rivastigmine Tartrate Capsules, Sun Pharma, Approval
Stimate (desmopressin acetate) Nasal Spray, CSL Behring, Formulation
Revision
Tasigna Oral Capsule, Novartis, Approval
Valsartan Tablet, Ranbaxy Labs, Tentative Approval
Zithromax (azithromycin) 250mg Capsules, Pfizer, Labeling Revision
Zithromax (azithromycin) Single-Dose Packet, Pfizer, Labeling Revision
Zithromax (azithromycin) 600mg Tablet, Pfizer, Labeling Revision
Zithromax (azithromycin) Oral Suspension, Pfizer Inc., Labeling Revision
Zithromax (azithromycin) 250mg Tablet, Pfizer Inc., Labeling Revision
Zithromax (azithromycin) 500mg Tablet, Pfizer Inc., Labeling Revision
Zithromax IV (azithromycin) Injection, Pfizer, Labeling Revision
Zmax (azithromycin extended release) Oral Suspension, Labeling Revision
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posted by Mags @ 8:47 AM,
,
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
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posted by Mags @ 6:38 AM,
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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
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posted by Mags @ 4:38 PM,
,