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Drug Evaluation & Research

CDERNEW-TEXT 8/30/2007

Thursday, August 30, 2007

August 30, 2007

New and Generic Drug Approvals
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm

Aloxi (palonosetron hydrochloride) Injection, Helsinn Healthcare, New
Dosage Regimen

Granisetron Hydrochloride Injection, Abraxis Pharma, Tentative Approval

Granisetron Hydrochloride Injection, Watson Labs, Tentative Approval

Serostim (somatropin [rDNA origin]) Injection, EMD Serono, Labeling
Revision

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 @ 4:06 PM,

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