October 25, 2004

• Drug Approval Reports
  • Biological Products Approved under Subpart E
  • CDER User Efficacy Supplements Approved in  Fiscal Year 2004
  • Efficacy Supplements Approved (Biologics) in Fiscal Year 2004
  • FY 2004 Priority Approvals
  • FY 2004 User Fee NME Drug and New Biologic Approvals
  • NDA and BLA Approvals for Calendar Year 2004
  • NDAs Approved under Subpart H

  • NDA Supplements Approved under Subpart H  

  • New Molecular Entity (NME) Drug and New Biologic Approvals in Calendar Year 2004 
• New and Generic Drug Approvals
  • Carvedilol Tablet, Ranbaxy, Tentative Approval
  • Diruil (chlorothiazide) intravenous Injection and tablets, Merck & Co., Labeling Revision
  • Evoclin (clindamycin phosphate) Foam, Connetics Corp, Approval
  • InnoPran XL (propranolol hydrochloride) Extended Release Capsules, Reliant, Labeling Revision
  • Mirtazapine Tablets, Aurobindo Pharma, Approval
  • Sustiva (efavirenz) tablets, GlaxoSmithKline, Labeling Revision
  • Sustiva (efavirenz) capsules, GlaxoSmithKline, Labeling Revision
  • Tikosyn (dofetilide) Capsules, Pfizer Inc., Labeling Revision
  • Xenical (Orlistat) Capsules, Hoffman-LaRoche, Efficacy Supplement with Clinical Data to Support

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