CDERNEW-TEXT 9/1 & 2/2007
Tuesday, October 2, 2007
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Guidance for Industry: New/Revised/Withdrawn List for 2007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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posted by Mags @ 5:07 PM,
