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November 27,
2009
November 25,
2009
November 24,
2009
November 23,
2009
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November 23,
2009
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ABILIFY
(aripiprazole)
Tablets,
Otsuka
Pharmaceutical
Company,
Ltd.,
Efficacy
Supp.
w/Clinical
Data
-
Altace
(ramipril)
Tablets,
King
Pharmaceuticals,
Inc.,
Labeling
Revision
-
Caffeine
Citrate
Oral
Solution,
Luitpold
Pharmaceuticals,
Inc.,
Approval
-
Calcipotriene
Topical
Solution,
Tolmar,
Inc.,
Approval
-
Cefotaxime
Sodium
Injection,
Aurobindo
Pharma
Ltd.,
Approval
-
Cleocin
Hydrochloride
(clindamycin
hydrochloride)
Capsules,
Pharmacia
& Upjohn
Co.,
Labeling
Revision
-
Cymbalta
(duloxetine
hydrochloride)
Delayed-Release
Capsules,
Lilly
Research
Laboratories,
Efficacy
Supp.
w/Clinical
Data
-
Ketorolac
Tromethamine
Ophthalmic
Solution,
Sun
Pharma
Global
Inc.,
Approval
-
Lopinavir
and
Ritonavir
Tablets,
Cipla
Ltd.,
Tentative
Approval
-
Lopressor
(metoprolol
tartrate)
Injection,
Novartis
Pharmaceuticals
Corp.,
Labeling
Revision
-
Lopressor
(metoprolol
tartrate)
Tablets,
Novartis
Pharmaceuticals
Corp.,
Labeling
Revision
-
Qualaquin
(quinine
sulfate)
Capsules,
AR
Holding
Company,
Inc.,
Labeling
Revision
-
REYATAZ
(atazanavir
sulfate)
Capsules,
Bristol-Myers
Squibb
Co.,
Efficacy
Supp.
w/Clinical
Data
-
SELZENTRY
(maraviroc)
Tablets,
ViiV
Healthcare
Company,
Efficacy
Supp.
w/Clinical
Data
-
Vytorin
(ezetimibe/simvastatin)
Tablets,
MSP
Singapore
Company,
LLC,
Labeling
Revision
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- Agriflu
Posted: 11/27/2009
- Jobs at the Center for Biologics Evaluation and Research (CBER)
Consumer Safety Officer, DCM/OCBQ, Posted: 11/27/2009
- Jobs at the Center for Biologics Evaluation and Research (CBER)
Program Analyst, PSB/DPS/OM, Posted: 11/27/2009
- Zostavax
11/16/2009 Approval Letter, Package Insert and Patient Information, Posted: 11/25/2009
- Influenza A (H1N1) 2009 Monovalent Vaccines Composition and Lot Release
Lot Release information, Updated: 11/24/2009
- Influenza Virus Vaccine for the 2009-2010 Season
Lot Release information, Updated: 11/24/2009
- Fluarix
10/2/2009 Approval letter, Posted: 11/24/2009
- Jobs at the Center for Biologics Evaluation and Research (CBER)
Regulatory Counsel, RPS/OD, Posted: 11/24/2009
- 2009 Meeting Materials, Cellular, Tissue and Gene Therapies Advisory Committee
October 9, 2009 Meeting Transcript, Posted: 11/23/2009
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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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RULES
- NONE |
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NOTICES |
Draft Guidance for Industry
and Food and Drug
Administration Staff:
Preliminary Timetable for the Review of Applications
for Modified Risk Tobacco
Products Under the Federal
Food, Drug, and Cosmetic
Act; Availability
6232962330 [E928515]
[TEXT] [PDF]
Meetings:
Cardiovascular and Renal Drugs Advisory Committee
62342 [E928302]
[TEXT] [PDF]
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RULES
- NONE |
|
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NOTICES
- NONE |
|
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RULES |
New Animal Drugs; Change of
Sponsor
6151661517 [E928217]
[TEXT] [PDF]
Organ-Specific Warnings:
Internal Analgesic, Antipyretic, and Antirheumatic Drug
Products for
Over-the-Counter Human Use,
etc.
6151261516 [E928296]
[TEXT] [PDF]
|
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NOTICES |
Guidance for Industry:
Residual Solvents in Drug Products Marketed in the
United States
6169261693 [E928247]
[TEXT] [PDF]
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RULES
- NONE |
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NOTICES
- NONE |
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RULES |
New Animal Drugs for Use in
Animal Feeds:
Change of Sponsor
6102861029 [E928009]
[TEXT] [PDF]
Melengestrol; Monensin; Tylosin
6102961030 [E928019]
[TEXT] [PDF]
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PROPOSED RULES |
Animal
Food Labeling:
Declaration of Certifiable Color Additives
6106861074 [E927984]
[TEXT] [PDF]
|
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NOTICES |
Debarment Orders:
Anthony W. Albanese
61151 [E928084]
[TEXT] [PDF]
Niaja Kane
6115061151 [E928083]
[TEXT] [PDF]
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