CDERNEW-TEXT 11/13/2007
Tuesday, November 13, 2007
November 13, 2007
Drug Approval Reports: Efficacy Supplement Approvals
http://www.fda.gov/cder/rdmt/ESCY07AP.htm
New and Generic Drug Approvals
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm
Arava (leflunomide) Tablets, Sanofi-Aventis, Labeling Revision
Crestor (rosuvastatin calcium) Tablets, IPR Pharma, New or Modified
Indication
ELIGARD (leuprolide acetate 45mg) for Injectable Suspension,
Sanofi-Aventis, Labeling Revision
ELIGARD (leuprolide acetate 30mg) for Injectable Suspension,
Sanofi-Aventis, Labeling Revision
ELIGARD (leuprolide acetate 22.5mg) for Injectable Suspension,
Sanofi-Aventis, Labeling Revision
ELIGARD (leuprolide acetate 7.5mg) for Injectable Suspension,
Sanofi-Aventis, Labeling Revision
Lamotrigine Tablets, Sandoz Inc., Tentative Approval
Optison (Perflutren Protein-Type A Micropheres) Injection, GE
Healthcare, Labeling Revision
SPRYCEL (dasatinib) Tablets, Bristol-Myers Squibb, New Dosage Regimen &
Efficacy Supp. w/Clinical Data
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posted by Mags @ 5:30 PM,
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