• New and Generic Drug Approvals
  • Cyclophosphamide Injection, Baxter Healthcare Corp., Approval
  • EES (erythromycin ethylsuccinate) Chewable Tablets, Abbott Laboratories, Labeling Revision
  • EES (erythromycin ethylsuccinate) Oral Granules, Abbott Laboratories, Labeling Revision
  • Eloxatin (oxaliplatin) Injection, Sanofi-Aventis US, Inc., Labeling Revision
  • Eloxatin (oxaliplatin) Injection, Sanofi-Aventis US, Inc., Efficacy Supplement with Clinical Data to Support
  • EryPed (erythromycin ethylsuccinate) Chewable Tablets, Abbott Laboratories, Labeling Revision
  • EryPed (erythromycin ethylsuccinate) Oral Granules, Abbott Laboratories, Labeling Revision
  • Fluoxetine (fluoxetine hydrochloride) Capsules, Teva Pharmaceuticals USA, Approval
  • Granisetron Hydrochloride Injection, Ebewe Pharmaceuticals, Inc., Tentative Approval 
  • Milrinone Lactate in Dextrose 5% in Plastic Container Injection, Bedford Laboratories, Inc., Approval
  • PCE (erythromycin) Tablets, Abbott Laboratories, Labeling Revision
  • Seroquel XR (quetiapine fumarate) Extended-Release Tablets, AstraZeneca Pharmaceuticals LP, Labeling Revision
• PDUFA Pilot Project - Proprietary Name Review: Draft Concept Paper
• Paragraph IV Patent Certifications (updated)

May 22, 2008

• New and Generic Drug Approvals
  • Biaxin (clarithromycin) Tablets, Abbott Laboratories, Labeling Revision
  • Biaxin (clarithromycin) Oral Suspension, Abbott Laboratories, Labeling Revision
  • Biaxin XL (clarithromycin) Extended-Release Tablets, Abbott Laboratories, Labeling Revision
  • Keflex (cephalexin) Capsules, Lex Pharmaceuticals, Inc., Labeling Revision
  • Noxafil (posaconazole) Oral Suspension, Schering Corp., Labeling Revision

May 21, 2008

• Drugs@FDA Downloadable Data Files (updated)
• FDA approves Entereg (alvimopan) to help restore bowel function following surgery. FDA News
• New and Generic Drug Approvals
  • Promethazine Hydrochloride Tablets, Impax Laboratories, Inc., Approval
  • Ropinirole Hydrochloride Tablets, Corepharma, LLC, Approval
  • Venlafaxine Hydrochloride Extended-Release Tablets, Osmotica Pharmaceutical Corp., Approval

May 20, 2008

• New and Generic Drug Approvals
  • Acetaminophen, Caffeine and Dihydrocodeine Bitartrate Capsules, E5 Pharma, Inc., Manufacturing Revision
  • Butorphanol Tartrate Preservative Free Injection, Apotex Corp., Control Supplement
  • Emtriva (emtricitabine) Capsules, Gilead Sciences, Inc., Efficacy Supplement with Clinical Data to Support 
  • Emtriva (emtricitabine) Oral Solution, Gilead Sciences, Inc., Efficacy Supplement with Clinical Data to Support
  • Norvir (ritonavir) Oral Solution, Abbott Laboratories, Labeling Revision
  • Norvir (ritonavir) Capsules, Abbott Laboratories, Labeling Revision
  • Tekturna (aliskiren hemifumarate) Tablets, Novartis Pharmaceuticals Corp., Labeling Revision
  • Truvada (emtricitabine and tenofovir disoproxil fumarate) Tablets, Gilead Sciences, Inc., Efficacy Supplement with Clinical Data to Support
  • Viread (tenofovir disoproxil fumarate) Tablets, Gilead Sciences, Inc., Efficacy Supplement with Clinical Data to Support

May 19, 2008

• New and Generic Drug Approvals
  • ATACAND HCT (candesartan cilexetil and hydrochlorothiazide) Tablets, AstraZeneca LP, Formulation Revision
  • Geodon (ziprasidone hydrochloride) Capsules, Pfizer, Inc., Labeling Revision
  • Geodon (ziprasidone mesylate) Injection, Pfizer, Inc., Labeling Revision
  • Granisetron Hydrochloride Injection, Wockhardt USA, Inc., Tentative Approval
  • Hydrochlorothiazide Capsules, Apotex Corp., Approval
  • Invega (paliperidone) Extended-Release Tablets, Janssen LP, Labeling Revision
  • Keppra (levetiracetam) Injection, UCB, Inc., New or Modified Indication 
  • Metoprolol Succinate Extended-Release Tablets, KV Pharmaceutical Co., Approval
  • Mitoxantrone Hydrochloride Injection, Dabur Oncology, Plc., Approval
  • Mycobutin (rifabutin) Capsules, Pharmacia and Upjohn Co., Labeling Revision
  • Nevirapine Tablets, Matrix Laboratories, Ltd., Tentative Approval
  • Topiramate Capsules, Cobalt Laboratories, Inc., Tentative Approval

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May 23, 2008 Guidance for Industry - Medical Device Tracking; Guidance for Industry and FDA Staff HHS News: New Efforts to Help Improve Medical Products for Patient Safety and Quality of Medical Care   May 22, 2008 Federal Register: Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting. Federal Register: Ophthalmic Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting.   May 20, 2008 FDA Workshop: Exploration of Public Policy Development Regarding the Study and Analysis of Sex Differences in the Clinical Evaluation of Cardiovascular Medical Products, June 2, 2008 Federal Register: Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Plasmodium Species Antigen Detection Assays; Availability. Federal Register: Medical Devices; Immunology and Microbiology Devices; Classification of Plasmodium Species Antigen Detection Assays.   May 19, 2008 Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Plasmodium Species Antigen Detection Assays

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