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Drug Evaluation & Research

CDERNEW-TEXT 10/16/2007


Wednesday, October 17, 2007

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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posted by Mags @ 10:05 AM,




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