Drug Evaluation & Research

CDERNEW-TEXT 11/13/2007

2007-11-13T17:30:00.000-06:00

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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CDERNEW-TEXT 11/7 - 9/2007

2007-11-09T17:41:00.000-06:00

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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CDERNEW-TEXT 11/5 & 6/2007

2007-11-06T17:15:00.000-06:00

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

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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CDERNEW-TEXT 11/1/2007

2007-11-01T17:01:00.000-05:00

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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CDERNEW-TEXT 10/31/2007

2007-11-01T11:23:00.000-05:00

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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CDERNEW-TEXT 10/29 & 30/2007

2007-10-31T08:47:00.000-05:00

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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CDERNEW-TEXT 10/24/2007

2007-10-25T06:38:00.000-05:00

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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CDERNEW-TEXT 10/22 & 23/2007

2007-10-23T16:38:00.000-05:00

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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CDERNEW-TEXT 10/17 - 19/2007

2007-10-19T19:05:00.000-05:00

October 19, 2007

Drug Shortage

Drug to be Discontinued; Exubera (insulin recombinant human, powder for
inhalation) http://www.fda.gov/cder/drug/shortages/default.htm#Exubera

Current Shortage: Valstar (valrubicin) Solution for Intravesical
Instillation http://www.fda.gov/cder/drug/shortages/default.htm#Valstar
(updated)

Paragraph IV Patent Certifications http://www.fda.gov/cder/ogd/ppiv.htm
(updated)

Manual of Policies and Procedures (MaPPs) Preparation of
Purchase/Service/Stock Requisitions in iProcurement 4631.2R
http://www.fda.gov/cder/mapp/4631.2R.pdf

Manual of Policies and Procedures (MaPPs) Interdisciplinary Review Team
for QT Studies 6020.14 http://www.fda.gov/cder/mapp/6020.14.pdf

Manual of Policies and Procedures (MaPPs) Management of CDER
Pharmacology/Toxicology Coordinating Committee 7400.1R
http://www.fda.gov/cder/mapp/7400.1R.pdf

October 18, 2007

Bioresearch Monitoring Information System (BMIS) download file
http://www.fda.gov/cder/foi/special/bmis/index.htm

(updated)

Drug Approval Report: Accelerated Approvals
http://www.fda.gov/cder/rdmt/accappr.htm

(updated)

FDA approves Doribax (doripenem), a new drug to treat complicated
urinary tract and intra-abdominal infections
http://www.fda.gov/bbs/topics/NEWS/2007/NEW01728.html .

FDA approves Isentress (raltegravir), a new drug to treat HIV infection
http://www.fda.gov/bbs/topics/NEWS/2007/NEW01726.html .

FDA issues questions and answers for Viagra, Levitra, Cialis, and
Revatio on possible sudden hearing loss
http://www.fda.gov/cder/drug/infopage/ed_drugs/QA.htm

Guidance for Industry: The Use of Mechanical Calibration of Dissolution
Apparatus 1 and 2 - Current Good Manufacturing Practice (CGMP) [PDF
http://www.fda.gov/cder/guidance/7232dft.pdf ] or [HTML
http://www.fda.gov/cder/guidance/7232dft.htm ]

October 17, 2007

Drugs@FDA Downloadable Data Files
http://www.fda.gov/cder/drugsatfda/datafiles/default.htm

(updated)

Inactive Ingredients Search
http://www.accessdata.fda.gov/scripts/cder/iig/index.cfm

(updated)

New and Generic Drug Approvals
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm

Ixempra Kit (ixabepilone) Injection, Bristol-Myers, Approval

Rhinocort Aqua (budesonide) Nasal Spray, AstraZeneca Pharma, Labeling
Revision

Venlafaxine Hydrochloride Extended-Release Capsules, Impax Labs,
Tentative Approval

Office of Generic Drugs: First-Time Generic Drug Approvals
http://www.fda.gov/cder/ogd/approvals/default.htm

(updated)

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CDERNEW-TEXT 10/16/2007

2007-10-17T10:05:00.000-05:00

October 16, 2007

AERS Quarterly Download, 2nd Quarter 2007
http://www.fda.gov/cder/aers/extract.htm

FDA issues an FDA Alert and Healthcare Professional Sheet for Exenatide
http://www.fda.gov/cder/drug/infopage/exenatide/default.htm

New and Generic Drug Approvals
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm

Alprazolam Extended-Release Tablets, Vintage Pharma, Approval

Chlorascrub Swabstick and Maxi Swabstick (chlorhexidine gluconate w/
isopropyl alcohol), PDI Healthcare, Package Change

Epirubicin Hydrochloride Injection, Abraxis Pharma, Approval

Fludarabine Phosphate Injection, Abraxis Pharma, Approval

Office of Nonprescription Products: Rulemaking History for
Nonprescription Products
http://www.fda.gov/cder/otcmonographs/rulemaking_index.htm

(updated)

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CDERNEW-TEXT 10/15/2007

2007-10-16T05:09:00.000-05:00

October 15, 2007

FDA Acronyms Search
http://www.accessdata.fda.gov/scripts/cder/acronyms/index.cfm

(updated)

New and Generic Drug Approvals
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm

Delestrogen (estradiol valerate) Injection, JHP Pharma, Manufacturing
Change or Addition

Doribax (doripenem) Injection, Johnson & Johnson, Approval

Isentress (raltegravir) Tablets, Merck & Co., Approval

Januvia (sitagliptin) Tablets, Merck & Co., New or Modified Indication

LEXIVA (fosamprenavir calcium; FPV) Oral Tablets, GlaxoSmithKline, New
Dosage Regimen

Lodine (etodolac) Capsules and Tablets, Wyeth Pharma, Labeling Revision

Nateglinide Tablets, Watson Labs, Tentative Approval

Oxcarbazepine Tablets, Apotex, Tentative Approval

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CDERNEW-TEXT 10/12/2007

2007-10-15T03:33:00.000-05:00

October 12, 2007

Dissolution Methods Database
http://www.accessdata.fda.gov/scripts/cder/dissolution/index.cfm
(updated)

Drug Master Files http://www.fda.gov/cder/dmf/index.htm

(updated)

Drug Shortage: Drug to be Discontinued; Sporanox
http://www.fda.gov/cder/drug/shortages/default.htm#Sporanox

FDA issues an FDA Alert and Healthcare Professional Sheet on 2
micro-bubble contrast agents, Definity and Optison
http://www.fda.gov/cder/drug/infopage/microbubble/default.htm

Guidance for Industry: Antibacterial Drug Products: Use of
Noninferiority Studies to Support Approval [PDF
http://www.fda.gov/cder/guidance/7884dft.pdf ] or [HTML
http://www.fda.gov/cder/guidance/7884dft.htm ]

New and Generic Drug Approvals
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm

HYCAMTIN (topotecan), GlaxoSmithKline, Approval

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CDERNEW-TEXT 10/11/2007

2007-10-11T17:23:00.000-05:00

October 11, 2007

Guidance for Industry: Postmarketing Adverse Event Reporting for
Nonprescription Human Drug Products Marketed without an Approved
Application [PDF http://www.fda.gov/cder/guidance/7950dft.pdf ]

New and Generic Drug Approvals
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm

DEFINITY (Perflutren Lipid Microsphere) Injectable Suspension,
Bristol-Myers Squibb, Labeling Revision

Omnipred (prednisolone acetate) Ophthalmic Suspension, Alcon Labs,
Labeling Revision

Oxcarbazepine Tablets, Glenmark Pharma, Approval

Oxcarbazepine Tablets, Sun Pharma, Approval

Oxcarbazepine Tablets, Roxane Labs, Approval

Simvastatin Orally Disintegrating Tablets, Synthon Pharma, Approval

Velcade (bortezomib) Injection, Millennium Pharma, Efficacy Supp.
w/Clinical Data

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CDERNEW-TEXT 10/10/2007

2007-10-10T16:34:00.000-05:00

October 10, 2007

Approved Drug Products with Therapeutic Equivalence Evaluations Orange
Book http://www.fda.gov/cder/orange/default.htm

Drug Shortage: Drug to be Discontinued; Agenerase (amprenavir) 150mg
capsule http://www.fda.gov/cder/drug/shortages/default.htm#Agenerase
(updated)

Drugs@FDA Downloadable Data Files
http://www.fda.gov/cder/drugsatfda/datafiles/default.htm

(updated)

FDA approves the first generic versions of Trileptal (oxcarbazepine), an
anticonvulsant drug
http://www.fda.gov/bbs/topics/NEWS/2007/NEW01721.html

New and Generic Drug Approvals
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm

Ambien (zolpidem tartrate) Tablets, Sanofi-Synthelabo, Labeling Revision

CUBICIN (daptomycin) Injection, Cubist Pharma, Labeling Revision

Depo-subQ provera 104 (medroxyprogesterone acetate injectable
suspension), Pfizer Global, Labeling Revision

Pexeva (paroxetine mesylate) Tablets, JDS Pharma, Labeling Revision

Prednisolone Sodium Phosphate Oral Solution, Pharmaceutical Associates,
Control Supp.

Risedronate Sodium Tablets, Teva Pharma, Approval

Romazicon (flumazenil) Injection, HLR Technology, Labeling Revision

Tamiflu (oseltamivir phosphate) Capsules, Hoffman La Roche, Labeling
Revision

Tamiflu (oseltamivir phosphate) Oral Suspension, Hoffman La Roche,
Labeling Revision

Prescription Drug User Fee Rates for Fiscal Year 2008
http://www.fda.gov/OHRMS/DOCKETS/98fr/OC2007240-n0000001.pdf PDF
http://www.fda.gov/graphics/pdf.gif

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CDERNEW-TEXT 10/10/2007

2007-10-10T10:36:00.000-05:00

October 9, 2007

BPCA/Pediatric Exclusivity Statistics:

Breakdown of Requested Studies Report
http://www.fda.gov/cder/pediatric/breakdown.htm

(updated)

Spectrum of Diseases/Conditions
http://www.fda.gov/cder/pediatric/specdis.htm

(updated)

Written Requests Issued http://www.fda.gov/cder/pediatric/wrlist.htm
(updated)

Written Requests Statistics
http://www.fda.gov/cder/pediatric/wrstats.htm

(updated)

CDER Organization Charts [HTML http://www.fda.gov/cder/cderorg.htm ]
[PDF http://www.fda.gov/cder/cderorg/cder-all.pdf ] (updated)

Current Drug Shortage

Solu-Cortef 100mg (Hydrocortisone sodium succinate) for injection
http://www.fda.gov/cder/drug/shortages/default.htm#Valstar

(updated)

Valstar (valrubicin) Solution for Intravesical Instillation
http://www.fda.gov/cder/whatsnew.htm#Valstar (updated)

New and Generic Drug Approvals
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm

Accutane (isotretinoin) Capsules, Hoffman La-Roche, Labeling Revision

Aptivus (tipranavir) Capsules, Boehringer Ingelheim Pharma, Accelerated
Approval

Cetirizine Hydrochloride Chewable Tablets, Caraco Pharma, Tentative
Approval

Estradiol Valerate Injection, Sandoz Inc., Approval

Granisetron Hydrochloride Injection, Abraxis Pharma, Tentative Approval

Hydrochlorothiazide Tablets, Apotex, Approval

Irinotecan Hydrochloride Injection, Abraxis Pharma, Tentative Approval

LEXXEL (enalapril maleate-felodipine ER) Tablets, AstraZeneca, Labeling
Revision

Nifedipine Extended-release Tablets, Osmotica Pharma, Approval

Qualaquin (quinine sulfate) Capsules, AR Holding Co., Labeling Revision

Sensipar (cinacalcet) Tablets, Amgen Inc., Labeling Revision

Torsemide Tablets, Apotex, Supplier Addition

Valacyclovir Hydrochloride Tablets, Teva Pharma, Tentative Approval

VUSION (miconazole nitrate, zinc oxide, white petrolatum) Ointment,
Barrier Therapeutics, Labeling Revision

Zestril (lisinopril) Tablets, AstraZeneca, Labeling Revision

Zestoretic (lisinopril/hctz) Tablets, AstraZeneca, Labeling Revision

Zoloft (sertraline hydrochloride) Tablets, Pfizer Pharma, Labeling
Revision

Zoloft (sertraline hydrochloride) Oral Concentrate, Pfizer Pharma,
Labeling Revision

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CDERNEW-TEXT 10/3 & 4/2007

2007-10-04T16:58:00.000-05:00

October 4, 2007

FDA announces the award of a contract to assist with the transformation
of FDA's Center for Drug Evaluation and Research
http://www.fda.gov/bbs/topics/NEWS/2007/NEW01718.html

New and Generic Drug Approvals
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm

Cordarone (amiodarone HCl) Tablets, Wyeth Pharma, Labeling Revision

Duetact (pioglitazone HCl plus glimepiride) Fixed-dose Combination
Tablets, Takeda Global, Formulation Revision

GEODON (ziprasidone HCl) Capsules, Pfizer Inc., Labeling Revision

GEODON (ziprasidone mesylate) Injection, Pfizer Inc., Labeling Revision

Linezolid Tablets, Teva Pharma, Tentative Approval

Metoprolol Tartrate Injection, Sandoz Pharma, Approval

NuvaRing (etonogestrel/ethinyl estradiol) Vaginal Ring, Organon Inc.,
Labeling Revision

Omnipaque (iohexol) Injection, GE Healthcare, Labeling Revision

October 3, 2007

Drugs@FDA Downloadable Data Files
http://www.fda.gov/cder/drugsatfda/datafiles/default.htm

(updated)

FDA acts to ensure that thyroid drugs don't lose their potency before
the expiration date. Levothyroxine Information
http://www.fda.gov/cder/drug/infopage/levothyroxine/default.htm

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CDERNEW-TEXT 9/1 & 2/2007

2007-10-02T17:07:00.000-05:00

October 2, 2007

CDER Organization Charts [HTML http://www.fda.gov/cder/cderorg.htm ]
[PDF http://www.fda.gov/cder/cderorg/cder-all.pdf ] (updated)

Guidance for Industry: Comprehensive List of Guidance Documents
http://www.fda.gov/cder/guidance/CompList102007.pdf

PDF
http://www.fda.gov/cder/graphics/pdf.gif

Guidance for Industry: New/Revised/Withdrawn List for 2007
http://www.fda.gov/cder/guidance/newrevwithdrawn200709.pdf PDF
http://www.fda.gov/cder/graphics/pdf.gif

New and Generic Drug Approvals
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm

Butisol Butabarbital Sodium Oral Solution, Medpointe Pharma, Labeling
Revision

Delsym (dextromethorphan polistirex) Extended-Release Suspension, Adams
Respiratory, Formulation Revision

LAMISIL (terbinafine hydrochloride) Oral Granules, Novartis Pharma,
Approval

Nevirapine Tablets, Emcure Pharma, Tentative Approval

Ofloxacin Otic Solution, Apotex, Approval

PROVERA (medroxyprogesterone acetate) Tablets, Pfizer Inc., Labeling
Revision

Strattera (atomoxetine hydrochloride) Capsules, Eli Lilly, Efficacy
Supp. w/Clinical Data

TAXOTERE (docetaxel) Injection Concentrate, Sanofi-aventis, New or
Modified Indication

Paragraph IV Patent Certifications http://www.fda.gov/cder/ogd/ppiv.htm
(updated)

Notice of Violation Letter: Cymbalta
http://www.fda.gov/cder/warn/warn2007.htm#September

October 1, 2007

FDA issues an Early Communication of an Ongoing Safety Review
http://www.fda.gov/cder/drug/early_comm/bisphosphonates.htm

for
bisphosphonates

Investigational Human Drugs: Clinical Investigator Inspection List
(CLIIL) http://www.fda.gov/cder/regulatory/investigators/default.htm
(updated)

New and Generic Drug Approvals
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm

Amlodipine Orally Disintegrating Tablets, Synthon Pharma, Approval

Amlodipine Besylate Tablets, Watson Labs, Approval

AZOR (amlodipine and olmesartan medoxomil) Tablets, Daiichi Sankyo,
Approval

Benicar (olmesartan medoxomil) Tablets, Daiichi Sankyo Inc., Labeling
Revision

Clopidogrel Bisulfate Tablets, Roxane Labs, Tentative Approval

Dovonex Scalp Solution, Warner Chilcott, Labeling Revision

Dovonex Cream, Warner Chilcott, Labeling Revision

Dovonex Ointment, Warner Chilcott, Labeling Revision

EPIVIR-HBV (lamivudine) Tablets, GlaxoSmithKline, Labeling Revision

EPIVIR-HBV (lamivudine) Oral Solution, GlaxoSmithKline, Labeling
Revision

Levophed (norepinephrine bitartrate) Injection, Hospira Inc., Package
Change

Morphine Sulfate Extended-release Tablets, KV Pharma, Approval

Taclonex Ointment, Warner Chilcott, Labeling Revision

Notice to Applicants Submitting Direct-to-Consumer Television
Advertisements for Advisory Review to CDER/CBER for Fiscal Year 2008
http://www.fda.gov/cder/ddmac/user_fees/DTC_notice.htm

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CDERNEW-TEXT 9/28/2007

2007-09-28T18:47:00.000-05:00

September 28, 2007

The Food and Drug Administration Amendments Act of 2007 is signed into
law http://www.fda.gov/oc/initiatives/advance/fdaaa.html

The Act http://www.fda.gov/oc/initiatives/HR3580.pdf

PDF
http://www.fda.gov/cder/graphics/pdf.gif

FDA takes action to stop marketing of unapproved hydrocodone products
http://www.fda.gov/cder/drug/unapproved_drugs/enforcement.htm

Manufacturers of gadolinium-based contrast agents for magnetic resonance
imaging issue a Dear Healthcare Professional Letter
http://www.fda.gov/medwatch/safety/2007/safety07.htm#Gadolinium

New and Generic Drug Approvals
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm

Actoplus Met (pioglitazone HCl and metformin HCl) fixed-dose combination
Tablets, Takeda Global, Labeling Revision

DUETACT (pioglitazone HCl plus glimepiride) fixed-dose combination
Tablets, Takeda Global, Labeling Revision

KALETRA (lopinavir/ritonavir) Capsules, Abbott Labs, Labeling Revision

Lamivudine Tablets, Aurobindo Pharma, Tentative Approval

Lipitor (atorvastatin calcium) Tablets, Pfizer Inc., Labeling Revision

Naftin Gel (naftifine hydrochloride 1%), Merz Pharma, Package Change

STROMECTOL (ivermectin) Tablets, Merck & Co., Labeling Revision

Prescription Drug User Fee Act (PDUFA) Billable Products
http://www.fda.gov/cder/biologics/pdufa/billable.pdf

PDF
http://www.fda.gov/cder/graphics/pdf.gif (updated)

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CDERNEW-TEXT 9/26 & 27/2007

2007-09-27T16:46:00.000-05:00

September 27, 2007

New and Generic Drug Approvals
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm

Abilify (aripiprazole) Tablets, Otsuka, Labeling Revision

Abilify (aripiprazole) DISCMELT, Otsuka, Labeling Revision

Abilify (aripiprazole) Oral Solution, Otsuka, Labeling Revision

Abilify (aripiprazole) Intramuscular Injection, Otsuka, Labeling
Revision

Albuterol Sulfate Inhalation Solution, Watson Labs, Approval

Gabapentin Capsules, Hikma Pharma, Approval

KALETRA (lopinavir/ritonavir) Tablets, Abbott Labs, Labeling Revision

KALETRA (lopinavir/ritonavir) Oral Solution, Abbott Labs, Labeling
Revision

Methimazole Tablets, Caraco Pharma, Approval

Symlin (pramlintide acetate) Injection, Amylin Pharma, Package Change

Zebeta (bisoprolol fumarate) Tablets, Duramed Pharma, Labeling Revision

Ziac (bisoprolol fumarate and hydrochlorothiazide) Tablets, Duramed
Pharma, Labeling Revision

September 26, 2007

Drug Safety Oversight Board meeting, 8/22/2007; public summary
http://www.fda.gov/cder/drug/DrugSafety/DSOBmeetings/DSOB20070822.htm

Drug Shortage: Indocyanine Green for Injection, USP (IC-GREEN)
http://www.fda.gov/cder/drug/shortages/default.htm#Indocyanine (updated)

Drugs@FDA Downloadable Data Files
http://www.fda.gov/cder/drugsatfda/datafiles/default.htm

(updated)

FDA issues a Public Health Advisory and Healthcare Professional Sheet
for Fentora (fentanyl buccal tablets). Drug Information
http://www.fda.gov/cder/drug/infopage/fentanyl_buccal/default.htm

Office of Generic Drugs - News and Announcements Section
http://www.fda.gov/cder/ogd/index.htm#new

(updated)

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CDERNEW-TEXT 9/24 - 25/2007

2007-09-26T09:55:00.000-05:00

September 25, 2007

New and Generic Drug Approvals
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm

Anzemet (dolasetron mesylate) Tablets, Sanofi-Aventis, Labeling Revision

Anzemet (dolasetron mesylate) Injection, Sanofi-Aventis, Labeling
Revision

HalfLytely and Bisacodyl Tablets Bowel Prep Kit (PEG-3350 sodium
bicarbonate & potassium chloride), Braintree Labs, New Dosage Regimen

Ofloxacin Otic Solution, Bausch & Lomb Inc., Tentative Approval

TussiCaps (Hydrocodone polistirex & Chlorpheniramine polistirex)
Extended-Release Capsules, Mallinckrodt Inc., Approval

September 24, 2007

New and Generic Drug Approvals
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm

BuSpar (buspirone HCl) Tablets, Bristol-Myers Squibb, Labeling Revision

CellCept (mycophenolate mofetil) Capsules, Roche Palo, Labeling Revision

CellCept (mycophenolate mofetil) Tablets, Roche Palo, Labeling Revision

CellCept (mycophenolate mofetil hydrochloride), Intravenous, Roche Palo,
Labeling Revision

CellCept (mycophenolate mofetil) Oral Suspension, Roche Palo, Labeling
Revision

Fludarabine Phosphate Injection, Ebewe Pharma, Approval

Hydroxychloroquine Sulfate Tablets, Zydus Pharma, Approval

Prednisolone Syrup, Vintage Pharma, Approval

Ranitidine Syrup, Pharmaceutical Assoc. Inc., Approval

Paragraph IV Patent Certifications http://www.fda.gov/cder/ogd/ppiv.htm
(updated)

TWC Global LLC, Inc., issues a recall of Axcil and Desirin, both
marketed as dietary supplements, because they contain undeclared analogs
of sildenafil. MedWatch Safety Information
http://www.fda.gov/medwatch/safety/2007/safety07.htm#Axcil

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CDERNEW-TEXT 9/20/2007

2007-09-21T10:10:00.000-05:00

September 20, 2007

New and Generic Drug Approvals
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm

Ciclopirox Topical Solution, Synerx Pharma, Approval

Ciclopirox Topical Solution, Hi-Tech Pharmacal, Approval

Ciclopirox Topical Solution, Teva Pharma, Approval

Ciclopirox Topical Solution, G & W Labs, Approval

Ciclopirox Topical Solution, Taro Pharma, Approval

Ciclopirox Topical Solution, Watson Labs, Approval

Ciclopirox Topical Solution, Perrigo Co., Approval

Ciclopirox Topical Solution, Tolmar Inc., Approval

Ciclopirox Topical Solution, Apotex, Approval

Ciclopirox Topical Solution, Actavis, Approval

Colgate Total (sodium fluoride and triclosan dentifrice paste),
Colgate-Palmolive, Manufacturing Change or Addition

Kionex (Sodium Polystyrene Sulfonate) Suspension, Paddock Labs, Approval

MEFOXIN (cefoxitin sodium) Injection, Merck & Co., Labeling Revision

OsmoPrep (sodium phosphate monobasic monohydrate & sodium phosphate
dibasic anhydrous) Tablets, Salix Pharma, Labeling Revision

Ranitidine Syrup, Apotex, Approval

VANCOCIN HCL (vancomycin) Injection, Baxter Healthcare, Labeling
Revision

Warning Letter: Site Inspection, Kunshan Chemical & Pharmaceutical
Company http://www.fda.gov/cder/warn/warn2007.htm#September

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CDERNEW-TEXT 9/18/2007

2007-09-19T13:12:00.000-05:00

September 18, 2007

Approved Active Moieties That Have Appeared On The National Institutes
Of Health's (NIH) Annual Priority List For Which FDA Has Issued A
Written Request For Pediatric Studies Under The Best Pharmaceuticals For
Children Act (BPCA) http://www.fda.gov/cder/pediatric/offpatwrlist.htm
(updated)

FDA launches the first issue of the FDA Drug Safety Newsletter
http://www.fda.gov/cder/dsn/default.htm , a publication for healthcare
professionals and the medical community.

New and Generic Drug Approvals
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm

CEFZIL (cefprozil) Tablets, Bristol-Myers Squibb, Labeling Revision

CEFZIL (cefprozil) Oral Suspension, Bristol-Myers Squibb, Labeling
Revision

Evista (raloxifene hydrochloride) Tablets, Eli Lilly, Approval

Gleevec (imatinib mesylate) Ttablets, Novartis Pharma, Efficacy Suppl.
w/Clinical Data

Imodium Advance (loperamide HCl and simethicone) Caplets, McNeil
Consumer, Formulation Revision

Lamotrigine Tablets, Zydus Pharma, Tentative Approval

Macrodantin (nitrofurantoin macrocrystals) Capsules, Proctor and Gamble,
Labeling Revision

MAXIPIME (cefepime hydrochloride) Powder for Injection, Bristol-Myers
Squibb, Labeling Revision

OMNICEF (cefdinir) Capsules, Abbott Labs, Labeling Revision

OMNICEF (cefdinir) Oral Suspension, Abbott Labs, Labeling Revision

SOMA (carisoprodol) Tablets, Medpointe Pharma, New Dosage Regimen

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CDERNEW-TEXT 9/17/2007

2007-09-18T14:04:00.000-05:00

September 17, 2007

Drug Shortage; Drug to be Discontinued; Ethmozine (moricizine
hydrochloride) 200mg, 250g, and 300mg tablets
http://www.fda.gov/cder/drug/shortages/default.htm#Ethmozine (updated)

FDA issues an Alert on the risk of QT prolongation and Torsades de
Pointes (TdP) in patients treated with Haldol (haloperidol). Drug
Information http://www.fda.gov/cder/drug/InfoSheets/HCP/haloperidol.htm

New PDUFA payment procedures for application and supplement fees
effective October 1, 2007
http://www.fda.gov/cder/pdufa/application_fees.htm#new

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CDERNEW-TEXT 9/13/2007

2007-09-14T09:36:00.000-05:00

September 13, 2007

Approved Drug Products with Therapeutic Equivalence Evaluations Orange
Book http://www.fda.gov/cder/orange/default.htm

Fentora (fentanyl buccal tablet)
http://www.fda.gov/medwatch/safety/2007/safety07.htm#Fentora

- Cephalon
issues two Dear Healthcare Professional Letters to inform prescribers
and other healthcare providers of important safety information regarding
Fentora.

New and Generic Drug Approvals
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm

Amlodipine Besylate Tablets, Lek Pharma, Approval

Cefazolin Injection, USP and Dextrose Injection, USP in the Duplex
Container, B. Braun Medical, Labeling Revision

Cefuroxime Injection and Dextrose Injection in the Duplex Container, B.
Braun Medical, Labeling Revision

Colgate Total (sodium fluoride and triclosan dentifrice) Toothpaste,
Colgate-Palmolive, Formulation Revision

Griseofulvin Oral Suspension, Ivax Pharma, Approval

Humulin R (insulin [rDNA origin]) Human Injection, Eli Lilly, Labeling
Revision

Ibuprofen Tablets, Northstar Healthcare, Approval

Lamotrigine Tablets, Dr. Reddy's Labs, Tentative Approval

Lamotrigine Chewable Tablets, Dr. Reddy's Labs, Tentative Approval

Levaquin (levofloxacin) Tablets, Ortho-McNeil Pharma, Patient Population
Altered

Levaquin (levofloxacin) Injection and Levaquin (levofloxacin in
dextrose) Injection, Ortho-McNeil Pharma, Patient Population Altered

Levaquin (levofloxacin) Oral Solution, Ortho-McNeil Pharma, Patient
Population Altered

Motrin (ibuprofen) Tablets, McNeil Pediatrics, Labeling Revision

Motrin (ibuprofen) Suspension, McNeil Pediatrics, Labeling Revision

Pantoprazole Sodium Delayed Release Tablet, Sun Pharma, Approval

Septra and Septra DS (trimethoprim/sulfamethoxazole) Tablets, Monarch
Pharma, Labeling Revision

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CDERNEW-TEXT 9/12/2007

2007-09-12T17:46:00.000-05:00

September 12, 2007

Drugs@FDA Downloadable Data Files
http://www.fda.gov/cder/drugsatfda/datafiles/default.htm

(updated)

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CDERNEW-TEXT 9/11/2007

2007-09-11T16:25:00.000-05:00

September 11, 2007

FDA issues an FDA Alert and Healthcare Professional sheet for Rocephin
(ceftriaxone) clarifying concomitant use with calcium-containing
products or solutions. Drug Information
http://www.fda.gov/cder/drug/infopage/ceftriaxone/default.htm

New and Generic Drug Approvals
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm

Carvedilol Tablets, Hikma Pharma, Approval

Cefotaxime Injection and Dextrose Injection, B. Braun Medical, Inc.,
Labeling Revision

Cromolyn Sodium Nasal Solution, QPharma, Approval

Tricor (fenofibrate) Tablets, Abbott Labs, Labeling Revision

Zolpidem Tartrate Tablets, Invagen Pharma, Approval

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CDERNEW-TEXT 9/10/2007

2007-09-10T18:03:00.000-05:00

September 10, 2007

CDER on CMC: 21st Century Pharmaceutical Manufacturing and Control
Strategies - A Changing Paradigm, October 15-16, 2007 Bethesda North
Marriott Hotel & Conference Center. Meeting information
http://www.aapspharmaceutica.com/meetings/pharmaFDAweb.html

New and Generic Drug Approvals
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm

Actos (pioglitazone HCl) Tablets, Takeda Global Research, Labeling
Revision

Alimta (pemetrexed) Injection, Eli Lilly & Co., Control Supplement

Humulin R (insulin human injection, USP [rDNA origin]), Eli Lilly & Co.,
Labeling Revision

Humulin N NPH (human insulin isophane suspension [rDNA origin]), Eli
Lilly & Co., Labeling Revision

Humulin 70/30 (70% human insulin isophane suspension/30% insulin human
injection, [rDNA origin]), Eli Lilly & Co., Labeling Revision

Humulin 50/50 (50% human insulin isophane suspension/50% insulin human
injection, [rDNA origin]), Eli Lilly & Co., Labeling Revision

Humalog (insulin lispro injection [rDNA origin]), Eli Lilly & Co.,
Labeling Revision

Humalog (insulin lispro injection [rDNA origin]), Eli Lilly & Co.,
Package Change

Humalog Mix 75/25 (75% insulin lispro protamine suspension/25% insulin
lispro injection [rDNA origin]), Eli Lilly & Co., Labeling Revision

Humalog Mix 75/25 (75% insulin lispro protamine suspension/25% insulin
lispro injection [rDNA origin]), Eli Lilly & Co., Package Change

Humalog Mix 50/50 (50% insulin lispro protamine suspension/50% insulin
lispro injection [rDNA origin]), Eli Lilly & Co., Labeling Revision

Humalog Mix 50/50 (50% insulin lispro protamine suspension/50% insulin
lispro injection [rDNA origin]), Eli Lilly & Co., Package Change

RELENZA (zanamivir) Inhalation, GlaxoSmithKline, Labeling Revision

Sectral (acebutolol hydrochloride) Capsules, Dr. Reddy's Labs, Labeling
Revision

Topiramate Tablets, Aurobindo Pharma, Tentative Approval

Totect (dexrazoxane) Injection, TopoTarget Inc., Approval

Pfizer issues a Dear Healthcare Professional Letter to inform healthcare
professionals of the presence of ethyl methanesulfonate in Viracept
(nelfinavir mesylate). MedWatch Safety Information
http://www.fda.gov/medwatch/safety/2007/safety07.htm#Viracept

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CDERWEEK-TEXT 9/4 - 7/2007

2007-09-07T17:48:00.000-05:00

September 7, 2007

BPCA/Pediatric Exclusivity Statistics:

Pediatric Exclusivity Statistics
http://www.fda.gov/cder/pediatric/exgrant.htm

(updated)

Written Requests Issued http://www.fda.gov/cder/pediatric/wrlist.htm
(updated)

Written Requests Statistics
http://www.fda.gov/cder/pediatric/wrstats.htm

(updated)

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

Amlodipine Besylate Tablets, Wockhardt, Approval

Carvedilol Tablets, Glenmark Pharma, Approval

Carvedilol Tablets, Aurobindo Pharma, Approval

Carvedilol Tablets, Lupin, Approval

Diovan HCT (valsartan/hydrochlorothiazide) Tablets, Novartis Pharma,
Labeling Revision

Inderal (propranolol hydrochloride) Tablets, Wyeth Pharma, Labeling
Revision

Omniscan (gadodiamide) Injection, GE Healthcare, Approval

Ondansetron Hydrochloride Tablets, West-ward Pharma, Approval

Topiramate Capsules, Mylan Pharma, Tentative Approval

Paragraph IV Patent Certifications http://www.fda.gov/cder/ogd/ppiv.htm
(updated)

September 6, 2007

FDA approves the first generic versions of Coreg (carvedilol). FDA News
http://www.fda.gov/bbs/topics/NEWS/2007/NEW01695.html

FDA approves Somatuline Depot (lanreotide acetate injection) for the
treatment of acromegaly. FDA News
http://www.fda.gov/bbs/topics/NEWS/2007/NEW01692.html

New and Generic Drug Approvals
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm

Amlodipine Besylate Tablets, Actavis, Approval

Carvedilol Tablets, Actavis Elizabeth, Approval

Carvedilol Tablets, Apotex Corp., Approval

Carvedilol Tablets, Caraco Pharma, Approval

Carvedilol Tablets, Dr. Reddy's Labs, Approval

Carvedilol Tablets, Mylan Pharma, Approval

Carvedilol Tablets, Ranbaxy, Approval

Carvedilol Tablets, Sandoz Inc., Approval

Carvedilol Tablets, Taro Pharma, Approval

Carvedilol Tablets, Teva Pharma, Approval

Carvedilol Tablets, Watson Labs, Approval

Carvedilol Tablets, Zydus Pharma, Approval

Ciclopirox Topical Solution, Watson Labs, Tentative Approval

Clarithromycin Oral Suspension, Sandoz Inc., Approval

Differin (adapalene) Gel, Galderma Labs, Manufacturing Change or
Addition

Duetact (pioglitazone HCl + glimepiride) Fixed-dose Combination Tablets,
Takeda Global, Package Change

Hydrochlorothiazide Tablets, Cadista Pharma, Approval

MDP Multidose Utilipak (Technetium Tc99m Medronate) Injection, GE
HealthCare, Labeling Revision

Mucinex (guaifenesin) Extended Release Bi-layer Tablets, Adams
Respiratory Therapeutics, Formulation Revision

Mucinex D (guaifenesin, pseudoephedrine HCl and 1200 mg guaifenesin/120
mg pseudoephedrine HCl) Extended Release Bi-layer Tablets, Adams
Respiratory Therapeutics, Formulation Revision

Mucinex DM (guaifenesin, dextromethorphan HBr and guaifenesin
dextromethorphan HBr) Extended Release Bi-layer Tablets, Adams
Respiratory Therapeutics, Formulation Revision

Ofloxacin Otic Solution, Alcon, Tentative Approval

Omniscan Injection, GE HealthCare, Labeling Revision

September 5, 2007

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

Magnevist (gadopentetate dimeglumine) Injection, Bayer HealthCare,
Labeling Revision

Mirtazapine Orally Disintegrating Tablets, Actavis Elizabeth, Tentative
Approval

MultiHance (gadobenate dimeglumine) Injection, Bracco Diagnostics,
Labeling Revision

MultiHance (gadobenate dimeglumine) Multipack Injection, Bracco
Diagnostics, Labeling Revision

Nystatin /Triamcinolone Acetonide Cream, Taro Pharma, Facility Addition

OptiMARK (gadoversetamide) Injection, Mallinckrodt Inc., Labeling
Revision

ProHance (gadoteridol) Injection, Bracco Diagnostics, Labeling Revision

Proquin (ciprofloxacin hydrochloride) Extended-Release Tablets, Depomed
Inc., Labeling Revision

Voltaren (diclofenac sodium) Ophthalmic Solution, Novartis Pharma,
Labeling Revision

September 4, 2007

New and Generic Drug Approvals
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm

Ranitidine Hydrochloride Tablets, Dr. Reddy's Labs, Approval

Trileptal (oxcarbazepine) Oral Solution, Novartis Pharma, Labeling
Revision

Trileptal (oxcarbazepine) Tablets, Novartis Pharma, Labeling Revision

Ultravist (brand of iopromide) Injection, Bayer HealthCare Pharma,
Labeling Revision

Pediatric Research Equity Act (PREA) Labeling Changes
http://www.fda.gov/cder/pediatric/Prea_label_post-mar_2_mtg.htm
(updated)

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CDERNEW-TEXT 9/7/2007

2007-09-07T17:41:00.000-05:00

September 7, 2007

BPCA/Pediatric Exclusivity Statistics:

Pediatric Exclusivity Statistics
http://www.fda.gov/cder/pediatric/exgrant.htm

(updated)

Written Requests Issued http://www.fda.gov/cder/pediatric/wrlist.htm
(updated)

Written Requests Statistics
http://www.fda.gov/cder/pediatric/wrstats.htm

(updated)

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

Amlodipine Besylate Tablets, Wockhardt, Approval

Carvedilol Tablets, Glenmark Pharma, Approval

Carvedilol Tablets, Aurobindo Pharma, Approval

Carvedilol Tablets, Lupin, Approval

Diovan HCT (valsartan/hydrochlorothiazide) Tablets, Novartis Pharma,
Labeling Revision

Inderal (propranolol hydrochloride) Tablets, Wyeth Pharma, Labeling
Revision

Omniscan (gadodiamide) Injection, GE Healthcare, Approval

Ondansetron Hydrochloride Tablets, West-ward Pharma, Approval

Topiramate Capsules, Mylan Pharma, Tentative Approval

Paragraph IV Patent Certifications http://www.fda.gov/cder/ogd/ppiv.htm
(updated)

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CDERNEW-TEXT 9/6/2007

2007-09-06T15:55:00.000-05:00

September 6, 2007

FDA approves the first generic versions of Coreg (carvedilol). FDA News
http://www.fda.gov/bbs/topics/NEWS/2007/NEW01695.html

FDA approves Somatuline Depot (lanreotide acetate injection) for the
treatment of acromegaly. FDA News
http://www.fda.gov/bbs/topics/NEWS/2007/NEW01692.html

New and Generic Drug Approvals
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm

Amlodipine Besylate Tablets, Actavis, Approval

Carvedilol Tablets, Actavis Elizabeth, Approval

Carvedilol Tablets, Apotex Corp., Approval

Carvedilol Tablets, Caraco Pharma, Approval

Carvedilol Tablets, Dr. Reddy's Labs, Approval

Carvedilol Tablets, Mylan Pharma, Approval

Carvedilol Tablets, Ranbaxy, Approval

Carvedilol Tablets, Sandoz Inc., Approval

Carvedilol Tablets, Taro Pharma, Approval

Carvedilol Tablets, Teva Pharma, Approval

Carvedilol Tablets, Watson Labs, Approval

Carvedilol Tablets, Zydus Pharma, Approval

Ciclopirox Topical Solution, Watson Labs, Tentative Approval

Clarithromycin Oral Suspension, Sandoz Inc., Approval

Differin (adapalene) Gel, Galderma Labs, Manufacturing Change or
Addition

Duetact (pioglitazone HCl + glimepiride) Fixed-dose Combination Tablets,
Takeda Global, Package Change

Hydrochlorothiazide Tablets, Cadista Pharma, Approval

MDP Multidose Utilipak (Technetium Tc99m Medronate) Injection, GE
HealthCare, Labeling Revision

Mucinex (guaifenesin) Extended Release Bi-layer Tablets, Adams
Respiratory Therapeutics, Formulation Revision

Mucinex D (guaifenesin, pseudoephedrine HCl and 1200 mg guaifenesin/120
mg pseudoephedrine HCl) Extended Release Bi-layer Tablets, Adams
Respiratory Therapeutics, Formulation Revision

Mucinex DM (guaifenesin, dextromethorphan HBr and guaifenesin
dextromethorphan HBr) Extended Release Bi-layer Tablets, Adams
Respiratory Therapeutics, Formulation Revision

Ofloxacin Otic Solution, Alcon, Tentative Approval

Omniscan Injection, GE HealthCare, Labeling Revision

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CDERNEW-TEXT 9/5/2007

2007-09-06T09:23:00.000-05:00