GXPNews.com - What's New With CDER CBER & CDRH July 7, 2006 - July 14, 2006
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Center for Drug Evaluation & Research (CDER)
Center for Device & Radiological Health (CDRH)
Center for Biological Evaluation & Research (CBER)
July 14, 2006
a.. Pediatric Exclusivity Labeling Changes (updated)
July 13, 2006 a.. Azathioprine Tablets, 50 mg - Recalled due to a packaging mixup with Methotrexate
July 12, 2006 a.. CDER Key Officials
b.. Drug Approval Reports
a.. Accelerated and Restricted Approvals Under Subpart H (drugs) and Subpart E (biologics)
b.. Efficacy Supplement Approvals
c.. NDA and BLA Approvals
d.. NME Drug and New Biologic Approvals
e.. Priority NDA and BLA Approvals
c.. Drugs@FDA Downloadable Data Files (updated)
d.. Drug Shortage: Current; Albuterol (IVAX) (updated)
e.. FDA approves Atripla, a fixed-dose combination of three widely-used antiretroviral drugs, in a single tablet taken once a day, alone or in combination with other antiretroviral products for the treatment of HIV-1 infection in adults. Drug Information
July 11, 2006 a.. Presentations from the 42nd Annual Meeting of the Drug Information Association, June 18-22, 2006, Philadelphia, PA
b.. Bioresearch Monitoring Information System (BMIS) File
c.. CDER Organization Charts [HTML] [PDF] (updated)
d.. Inactive Ingredient Search
e.. New and Generic Drug Approvals
a.. Cephalexin Oral Suspension, Orchid healthcare, Approval
b.. Didanosine Tablets, Aurobindo Pharma, Tentative Approval
c.. RETROVIR (zidovudine) IV Solution, GlaxoSmithKline, Labeling Revision
d.. WelChol (colesevelam HCL) Tablets, Daiichi Sankyo, Labeling Revision
July 10, 2006 a.. Manual of Policies and Procedures (MaPP) 5210.5 Review of Investigational New Drug Applications (Bio-INDs) by the Office of Generic Drugs
b.. Manual of Policies and Procedures (MaPP) 5210.6 Procedures for Review of Bioequivalence Study Protocols
c.. National Drug Code Directory Download Files
d.. National Drug Code Directory Search
July 7, 2006 a.. Electronic Common Technical Document (eCTD): Study Data Specifications (updated)
b.. Office of Generic Drugs:
a.. June Approvals
b.. June First-Time Generics
c.. June Tentative Approvals
d.. Paragraph IV Patent Certifications (updated)
e.. Suitability Petitions (updated)
c.. BPCA/Pediatric Exclusivity Statistics:
a.. Breakdown of Requested Studies Report (updated)
b.. Written Requests Issued (updated)
c.. Pediatric Exclusivity Statistics (updated)
d.. Spectrum of Diseases/Conditions (updated)
d.. Division of Medical Imaging and Hematology Products Presentations at the Annual Society of Nuclear Medicine Meeting, June, 2006
e.. New and Generic Drug Approvals
a.. Amiodarone Hydrochloride Injection, Akron, Inc., Approval
b.. Azithromycin Oral Suspension, Pliva, Approval
c.. Biaxin (Clarithromycin) Filmtab, Abbott Labs, Labeling Revision
d.. Biaxin (Clarithromycin) Granules, Abbott Labs, Labeling Revision
e.. Biaxin XL (Clarithromycin) Filmtab, Abbott Labs, Labeling Revision
f.. Fosinopril Sodium & Hydrochlorothiazide Tablets, Teva Pharma, Approval
g.. Gabapentin Tablets, Sandoz, Inc., Approval
h.. Ondansetron Hydrochloride Tablets, Pliva, Tentative Approval
i.. Oxytrol (oxybutynin chloride) transdermal system, Watson Labs, Labeling Revision
j.. Warfarin Sodium Tabelts, Pliva, Approval
July 6, 2006 a.. Drugs@FDA Downloadable Data Files (updated)
July 5, 2006 a.. The Adverse Event Reporting System (AERS) Latest Quarterly Data Files
b.. Investigational Human Drugs: Clinical Investigator Inspection List (CLIIL)
c.. Ketek (telithromycin) Information (updated)
a.. Questions and Answers on Ketek
d.. Patient Information Sheet for Advair HFA (fluticasone propionate; salmeterol xinafoate) [HTML] [PDF]
e.. New and Generic Drug Approvals
a.. Citalopram Hydrobromide Tablets, Mutual Pharma, Approval
b.. Omacor (omega-3-acid ethyl esters) Capsules, Reliant Pharma, Manufacturing Change or Addition
c.. Symbyax (olanzapine and fluoxetine HCl) capsules, Eli Lilly & Co., Labeling Revision
d.. Triglide (fenofibrate) Tablets, First Horizon Pharma, Labeling Revision
e.. Vytorin (ezetimibe/simvastatin) Tablets, Merck & Co., Labeling Revision
f.. Wellbutrin Immediate Release Tablets GlaxoSmithKline, Labeling Revision
g.. Wellbutrin SR (bupropion hydrochloride) Sustained-Release Tablets, GlaxoSmithKline, Labeling Revision
h.. Wellbutrin XL (bupropion hydrochloride) Extended-Release Tablets, GlaxoSmithKline, Labeling Revision
f.. QbR-Quality Overall Summary Outline [Word]
July 3, 2006 a.. BPCA/Pediatric Exclusivity Statistics: Pediatric Exclusivity Granted
b.. CDER Organization Charts [HTML] [PDF] (updated)
c.. On June 30, FDA approved Lucentis (ranibizumab injection) for the treatment of patients with neovascular (wet) age-related macular degeneration. FDA News
d.. On June 30, FDA granted tentative approval to a three-component AIDS drug in association with the President's Emergency Plan for AIDS Relief. FDA News
e.. New and Generic Drug Approvals
a.. Alprazolam Extended-Release Tablets, Sandoz Inc., Approval
b.. Carbatrol (carbamazepine) extended-release capsules, Shire Dev., Labeling Revision
c.. Cefprozil Oral Suspension, Ranbaxy, Inc., Approval
d.. EMEND (aprepitant) Capsules, Merck & Co., New or Modified Indication
e.. Fluticasone Propionate Cream, G & W Labs, Approval
f.. Lamivudine, Zidovudine, Nevirapine Tablets, Aurobindo Pharma, Tentative Approval
g.. Lidocaine and Tetracaine Cream, Zars, Inc., Approval
h.. Lucentis (Ranibizumab) Injection, Genentech, Inc., Approval
i.. Sertraline Hydrochloride Oral Concentrate, Roxane Labs, Approval
j.. Sertraline Hydrochloride Tablets, Ivax Pharma, Approval
k.. Xyrem (sodium oxybate) oral solution, Jazz Pharma, Labeling Revision July 14, 2006
Federal Register: Medical Devices; Anesthesiology Devices; Neurological Devices; Denial of Request for Change in Classification of Breathing Requency Monitor and Electroencephalograph.
July 13, 2006
Ophthalmic Devices Panel Meeting, July 14, 2006 - Draft Agenda, Roster, Final Questions, and Briefing Information Available
July 11, 2006
FDA Update Statement on Boston Scientific/Guidant Pacemakers and Defibrillators
July 10, 2006
FDA Patient Safety News for July
July 7, 2006
Class I Medical Device Recall: Welch Allyn PIC 50 Automated External Defibrillators
FDA Statement on Blood Product Advisory Committee Meeting on Proposed Clinical Trial for Blood Substitute Product
Posted: 7/14/2006
Guidance for Industry: Providing Regulatory Submissions to the Center for Biologics Evaluation and Research (CBER) in Electronic Format - Lot Release Protocols
Posted: 7/12/2006; Issued: 7/12/2006 Vacancy Announcement - Administrative Support Assistant (OA), DE/OBE
Posted: 7/12/2006 Warning Letter - Envita Natural Medical Centers of America
Posted: 7/11/2006; Issued: 6/14/2006 Failure to Register Notice (FDA Annual Registration Form 3356)
Posted: 7/11/2006 Fast Track Designation Request Performance - Updated
Posted: 7/10/2006 Recall of Decavac Vaccine - (Amerisource Bergen / Sanofi Pasteur, Inc.) - Update
Posted: 7/7/2006 Licensed Products and Establishments List - Update
Posted: 7/6/2006, Updated through: 6/30/2006 Vacancy Announcement - Epidemiologist, VSB/DE/OBE
Posted: 7/6/2006 Approved Biological NDA and ANDA Applications - Update
Posted: 7/5/2006, Updated through: 6/30/2006 Cleared Biological 510(k) Device Applications - Update
Posted: 7/5/2006, Updated through: 6/30/2006 Approved Biological Premarket Approval (PMA) Device Applications - Update
Posted: 7/5/2006, Updated through: 6/30/2006
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