• Drug Master Files (updated)
• Drugs Shortages: Current Drug Shortages: Vinblastine Sulfate Injection (updated)
• Drugs@FDA Downloadable Data Files (updated)
• New and Generic Drug Approvals
  • Astepro (azelastine hydrochloride), MedPointe Pharmaceuticals, Nasal Spray, Approval
  • Atrovent (ipratropium bromide) Nasal Spray, Boehringer Ingelheim, Labeling Revision
  • Atrovent HFA (ipratropium bromide) Inhalation Aerosol, Boehringer Ingelheim Pharmaceuticals, Inc., Labeling Revision
  • Ceftazidime Injection, Wockhardt Ltd., Approval
  • Cefuroxime Sodium Intramuscular I.V. Injection, Orchid Healthcare, Approval
  • Cefuroxime Sodium Intramuscular I.V. Injection, Orchid Healthcare, Approval
  • Lexapro (escitalopram oxalate) Oral Solution, Forest Laboratories, Inc., Labeling Revision
  • Lexapro (escitalopram oxalate) Tablets, Forest Laboratories, Inc., Labeling Revision
  • Mycophenolate Mofetil Capsules, Sandoz Inc., Approval
  • Mycophenolate Mofetil Tablets, Sandoz Inc., Approval
  • Tobi (tobramycin) Inhalation Solution, Novartis Pharmaceuticals Corp., Labeling Revision
  • Zomig (zolmitriptan) Nasal Spray, AstraZeneca, Patient Population Altered
• Warning Letters
  • Clinical Investigation, Gregory Gardziola
  • Clinical Investigation, Richard Holub, M.D.

October 22, 2008

• Drugs Shortages: Current Drug Shortages: Vinblastine Sulfate Injection
• Drugs Shortages: Resolved Drug Shortages: Proglycem (diazoxide) oral suspension

October 21, 2008

• Guidance for Industry: Tropical Disease Priority Review Vouchers [PDF]

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October 23, 2008 Federal Register: Agency Information Collection Activities; Proposed Collection; Comment Request; Electronic Data Collection Using MedWatch\Plus\ Portal and Rational Questionnaire   October 21, 2008 FDA Public Health Notification: Serious Complications Associated with Transvaginal Placement of Surgical Mesh in Repair of Pelvic Organ Prolapse and Stress Urinary Incontinence Information on Surgical Mesh for Hernia Repairs Information on Surgical Mesh for Pelvic Organ Prolapse and Stress Urinary Incontinence   October 20, 2008 PMA Final Decisions for September 2008     News & Events • Falsely Elevated Blood Glucose Readings with a Point-of-Care Meter Due to a Maltose-Containing Intravenous Immune Globulin Product • Certification to Accompany Drug, Biological Product, and Device Applications or Submissions Public Health Notifications: • Radiofrequency Ablation of Lung Tumors - Clarification of Regulatory Status • Possible Malfunction of Electronic Medical Devices Caused by Computed Tomography (CT) Scanning Class I Medical Device Recalls - • Physio Control, Inc. LifePak CR Plus Automated External Defibrillators (AEDs) • Pacific Consolidated Industries LLC, Mobile Oxygen Storage Tank • Boston Scientific NexStent Monorail, NexStent Carotid Stent and Monorail Delivery System   FDA Patient

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