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November 20, 2009
November 19, 2009
November 18, 2009
November 17, 2009
November 16, 2009
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November 20, 2009
- Acetaminophen Extended-Release Tablets, Ranbaxy Laboratories, Ltd., Approval
- Actoplus Met (pioglitazone hydrochloride and metformin hydrochloride) Tablets, Takeda Global Research & Development Center, Inc., Labeling Revision
- Calcipotriene Topical Solution, Hi-Tech Pharmacal Co., Inc., Approval
- Ciprofloxacin in Dextrose 5% in Plastic Container Injection, West-Ward Pharmaceutical Corp., Approval
- Cordarone (amiodarone hydrochloride) Tablets, Wyeth Pharmaceuticals, Inc., Labeling Revision
- Dorzolamide Hydrochloride Ophthalmic Solution, PharmaForce, Inc., Approval
- Dorzolamide Hydrochloride and Timolol Mealeate Ophthalmic Solution, Alcon Research, Ltd., Approval
- Geodon (ziprasidone hydrochloride) Capsules, Pfizer, Inc., Efficacy Supplement with Clinical Data to Support
- Lamisil AT (terbinafine hydrochloride) Topical Cream, Novartis Consumer Health, Labeling Revision
- Nizatidine Oral Solution, Amneal Pharmaceuticals, Approval
- Revatio (sildenafil) Injection, Pfizer, Inc., Approval
- Vimpat (lacosamide) Tablets, Schwarz Biosciences, Inc., Labeling Revision
- Vimpat (lacosamide) Injection, Schwarz Biosciences, Inc., Labeling Revision
November 19, 2009
- Adenocard (adenosine) Injection, Astellas Pharma US, Inc., Labeling Revision
- Methocarbamol Tablets, Hetero Drugs Ltd. Unit III, Approval
- Nicardipine Hydrochloride Injection, PharmaForce, Inc., Approval
- Nicardipine Hydrochloride Injection, GeneraMedix, Inc., Approval
- Nicardipine Hydrochloride Injection, Navinta, LLC., Approval
- Nicardipine Hydrochloride Injection, Sun Pharma Global Inc., Approval
- Nicardipine Hydrochloride Injection, Wockhardt Limited, Approval
- Norethindrone Acetate and Ethinyl Estradiol Tablets, Barr Laboratories, Inc., Approval
- RETROVIR (zidovudine) Capsules, GlaxoSmithKline, Labeling Revision
- RETROVIR (zidovudine) Syrup, GlaxoSmithKline, Efficacy Supp. w/Clinical Data
- Truvada (emtricitabine and tenofovir disoproxil fumarate) Tablets, Gilead Sciences, Inc., Labeling Revision
- Zestril (lisinopril) Tablets, AstraZeneca Pharmaceuticals, Labeling Revision
- Zestoretic (lisinopril and hydrochlorothiazide) Tablets, AstraZeneca Pharmaceuticals, Labeling Revision
- Ziac (bisoprolol fumarate and hydrochlorothiazide) Tablets, Duramed Pharmaceuticals, Inc., Labeling Revision
November 18, 2009
- Adenosine Injection, Akorn Inc., Tentative Approval
- Betaxolol Ophthalmic Solution, Wockhardt Ltd., Approval
- Butalbital, Acetaminophen and Caffeine Capsule, NexGen Pharmaceuticals, Approval
- Famotidine Tablets, Ranbaxy Laboratories Ltd., Approval
- Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablets, Dr. Reddy's Laboratories Ltd., Tentative Approval
- Lysteda (tranexamic acid) Tablets, Xanodyne Pharmaceuticals, Inc., Approval
- Qutenza (capsaicin) Patch, Neurogesx, Inc., Approval
- Rilutek (riluzole) Tablets, Sanofi Aventis U.S., L.L.C., Labeling Revision
- Soma Compound (aspirin and carisoprodol) Tablets, Meda Pharmaceuticals, Inc., Labeling Revision
- Soma (carisoprodol) Tablets, Meda Pharmaceuticals, Inc., Labeling Revision
November 16, 2009
- Eovist (gadoxetate disodium) Injection, Bayer HealthCare Pharmaceuticals, Manufacturing Change or Addition
- Imatinib Mesylate Tablets, Sun Pharmaceutical Industries Ltd., Tentative Approval
- Nucynta (tapentadol hydrochloride) Tablets, Ortho-McNeil-Janssen Pharmaceuticals, Inc., Labeling Revision
- REBETOL (ribavirin) Oral Solution, Schering Corporation, Labeling Revision
- Rheumatrex (methotrexate sodium) Tablets, Dava Pharmaceuticals, Inc., Manufacturing Change or Addition
- Tramadol Hydrochloride Extended-Release Tablets, Par Pharmaceutical, Inc., Approval
- Ultravist (iopromide) Injection, Bayer HealthCare Pharmaceuticals, Manufacturing Change or Addition
- Ultravist (iopromide) Injection Pharmacy Bulk Packaging, Bayer HealthCare Pharmaceuticals, Manufacturing Change or Addition
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- Influenza Virus Vaccine Actions
Updated: 11/20/2009
- Complete List of Substantially Equivalent 510(k) Device Applications (PDF - 363KB)
Updated: 11/20/2009
- Complete List of Currently Approved Premarket Approvals (PMAs) (PDF - 28KB)
Updated: 11/20/2009
- Complete List of Currently Approved NDA and ANDA Application Submissions (PDF - 60KB)
Updated: 11/20/2009
- ALBAclone (Alba Bioscience Limited)
Posted: 11/19/2009
- December 15, 2009: Vaccines & Related Biological Products Advisory Committee Meeting Announcement
Posted: 11/19/2009
- Jobs at the Center for Biologics Evaluation and Research (CBER)
Mathematical Statistician, Posted: 11/19/2009
- Influenza A (H1N1) 2009 Monovalent Vaccines Composition and Lot Release
Lot release information, Updated: 11/18/2009
- Influenza Virus Vaccine for the 2009-2010 Season
Lot release information, Updated: 11/18/2009
- Complete List of Licensed Products and Establishments
Information Updated through October 31, 2009, Updated: 11/18/2009
- Gardasil
Statistical and Clinical Reviews for 10/16/2009 approval of new indication, Posted: 11/17/2009
- Jobs at the Center for Biologics Evaluation and Research (CBER)
Research Biologist (OVRR/DBPAP/LRSP), Posted: 11/17/2009
- November 18-19, 2009: Vaccines and Related Biological Products Advisory Committee Briefing Documents
Briefing documents posted for November 19, 2009 meeting, Updated: 11/17/2009
- November 18-19, 2009: Vaccines and Related Biological Products Advisory Committee Briefing Documents
Briefing documents posted for November 18, 2009 meeting, Updated: 11/16/2009
- Jobs at the Center for Biologics Evaluation and Research (CBER)
Consumer Safety Officer (OCOD/DDOM/EDT), Updated: 11/16/2009
- Influenza A (H1N1) 2009 Monovalent Vaccines Descriptions and Ingredients
Updated: 11/16/2009
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FDA
Clinical
Investigator
Training
Course
Co-sponsored
by
FDA's
Office
of
Critical
Path
Programs
and
the
Clinical
Trials
Transformation
Initiative
(CTTI),
with
support
from
the
National
Institutes
of
Health
|
|
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- About CBER
- CBER Vision & Mission
Biologics Research, Regulatory Information, Safety & Availability, Guidances, Development & Approval, Enforcement & Compliance
- News & Events (Biologics)
What's New, Meetings & Workshops
- CBER Reports
CBER Annual Report, Performance, FDAMA, PDUFA, FDAAA, PREA
- Biologics Regulated Products
Allergenics, Blood & Blood Products, Cellular & Gene Therapy Products, Tissue & Tissue Products, Vaccines, Xenotransplantation
- Contacts in the Center for Biologics Evaluation & Research (CBER)
Consumer questions, manufacturer's assistance, media inquiries, technical questions, requesting speakers, establishment registration...
- Jobs at the Center for Biologics Evaluation and Research (CBER)
- Frequently Asked Questions about the Center for Biologics Evaluation and Research (CBER) and the Products CBER Regulates
- Biologics Electronic Reading Room (eFOI)
Documents frequently requested through the Freedom of Information Act.
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November 19, 2009
November 18, 2009
November 17, 2009
November 16, 2009
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RULES |
Oral
Dosage Form New Animal
Drugs:
Sulfadimethoxine
60155–60156 [E9–27885]
[TEXT] [PDF]
|
|
NOTICES |
Agency Information
Collection Activities;
Proposals, Submissions, and
Approvals
60265–60276 [E9–27956]
[TEXT] [PDF]
Guidance for Industry on
Changes to Approved New
Animal Drug Applications:
New Animal Drug Applications Versus Category II
Supplemental New Animal Drug
Applications; Availability
60277 [E9–27926]
[TEXT] [PDF]
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RULES |
New Animal Drugs for Use in
Animal Feeds:
Melengestrol; Monensin
59911–59912 [E9–27744]
[TEXT] [PDF]
|
|
NOTICES |
Draft Guidance for Industry:
Recommendations for the
Assessment of Blood Donor
Suitability, Blood Product
Safety, etc., in Response to
Pandemic (H1N1) 2009 Virus
59982–59983 [E9–27729]
[TEXT] [PDF]
Meetings:
Endocrinologic and Metabolic Drugs Advisory Committee
59986 [E9–27741]
[TEXT] [PDF]
Vaccines and Related Biological Products Advisory
Committee
59983–59984 [E9–27728]
[TEXT] [PDF] |
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RULES
- NONE |
|
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NOTICES |
Agency Information
Collection Activities;
Proposals, Submissions, and
Approvals
59545–59549 [E9–27658]
[TEXT] [PDF]
59558–59560 [E9–27659]
[TEXT] [PDF]
59556–59557 [E9–27716]
[TEXT] [PDF]
59555–59556 [E9–27719]
[TEXT] [PDF]
59553–59554 [E9–27720]
[TEXT] [PDF]
Filing of Color Additive
Petitions:
Sauflon Pharmaceuticals Ltd.
59560 [E9–27629]
[TEXT] [PDF]
Meetings:
Anti-Infective Drugs Advisory Committee; Admendment
59570–59571 [E9–27693]
[TEXT] [PDF]
Risk Evaluation and Mitigation Strategies for Certain Opioid
Drugs
59568–59569 [E9–27718]
[TEXT] [PDF]
Memorandum of Understanding
Between Food and Drug
Administration and
Waterfront Media
59571–59578 [E9–27630]
[TEXT] [PDF]
Request for Comments and for
Scientific Data and
Information:
Acrylamide in Food
59579 [E9–27692]
[TEXT] [PDF]
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RULES |
Certain Other Dosage Form
New Animal Drugs:
Progesterone Intravaginal Inserts
59073–59074 [E9–27497]
[TEXT] [PDF]
|
|
NOTICES |
Agency Information
Collection Activities;
Proposals, Submissions, and
Approvals
59188–59189 [E9–27512]
[TEXT] [PDF]
Meetings:
General and Plastic Surgery Devices Panel of the
Medical Devices Advisory
Committee
59194–59195 [E9–27491]
[TEXT] [PDF]
National Mammography Quality Assurance Advisory
Committee
59193 [E9–27492]
[TEXT] [PDF]
Oncologic Drugs Advisory Committee
59195 [E9–27490]
[TEXT] [PDF]
59193–59194 [E9–27493]
[TEXT] [PDF]
Public Workshops:
Thermal Aspects of Radio Frequency Exposure
59205–59206 [E9–27513]
[TEXT] [PDF]
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RULES |
Listing of Color Additives
Exempt From Certification:
Paracoccus Pigment
58843–58846 [E9–27394]
[TEXT] [PDF]
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NOTICES |
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