• Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) (updated)
• International Conference on Harmonization (ICH) Public Meeting, October 21, 2008, Rockville, Maryland: Meeting information and registration - (updated)
• Podcast Transcript - Measures Undertaken to Address Concerns about Marketing of Unapproved Drugs

October 9, 2008

• Drugs Shortages: Cureent Drug Shortages: Ultra-TechneKow DTE (Technetium Tc 99m Generator) NDA 17-243 (updated)
• FDA Statement Following CHPA's Announcement on Nonprescription Over-the-Counter Cough and Cold Medicines in Children
• New and Generic Drug Approvals
  • Akten (lidocaine hydrochloride) Ophthalmic Gel, Akorn Inc., Approval
  • Cetirizine Hydrochloride Syrup, Cypress Pharmaceutical, Inc., Approval
  • Children’s Claritin (loratadine) Chewable Tablets, Schering-Plough HealthCare Products, Inc., Control Supplement
  • Fluconazole Tablets, Aurobindo Pharma, Ltd., Approval
  • Ketorolac Tromethamine Injection, Sun Pharma Global Inc., Approval
  • Lamivudine Tablets, Macleods Pharmaceuticals, Ltd., Tentative Approval
  • Proquin XR (ciprofloxacin hydrochloride) Extended-Release Tablets, Depomed, Inc., Labeling Revision
  • Zmax (azithromycin) Extended-Release Oral Suspension, Pfizer Inc., Patient Population Altere

October 8, 2008

• Drugs@FDA Downloadable Data Files (updated)
• New and Generic Drug Approvals
  • Avelox (moxifloxacin hydrochloride) Tablets, Bayer Pharmaceuticals Corp., Labeling Revision
  • Avelox In Sodium Chloride 0.8% In Plastic Container (moxifloxacin hydrochloride) I.V. Injection, Bayer Pharmaceuticals Corp., Labeling Revision
  • Factive (gemifloxacin mesylate) Tablets, Oscient Pharmaceuticals Corp., Labeling Revision
  • Floxin (ofloxacin) Tablets, Ortho McNeil-Janssen Pharmaceutical, Inc., Labeling Revision
  • Levaquin (levofloxacin) Oral Solution, Ortho McNeil-Janssen Pharmaceutical, Inc., Labeling Revision
  • Levaquin (levofloxacin) Tablets, Ortho McNeil-Janssen Pharmaceutical, Inc., Labeling Revision
  • Levaquin In Dextrose 5% In Plastic Container (levofloxacin) Injection, Ortho McNeil-Janssen Pharmaceutical, Inc., Labeling Revision
  • Noroxin (norfloxacin) Tablets, Merck & Co., Inc., Labeling Revision

October 7, 2008

• FDA issues an updated Early Communication about an Ongoing Safety Review of Tiotropium (marketed as Spiriva HandiHaler). Information
• Guidance for Industry: PDUFA Pilot Project: Proprietary Name Review (finalized) [PDF]
• New and Generic Drug Approvals
  • Arsenic Trioxide Injection, Teva Parenteral Medicines, Inc., Tentative Approval
  • Cipro (ciprofloxacin) Injection, Bayer Pharmaceuticals Corp., Labeling Revision
  • Cipro (ciprofloxacin) Oral Suspension, Bayer Pharmaceuticals Corp., Labeling Revision
  • Cipro (ciprofloxacin hydrochloride) Tablets, Bayer Pharmaceuticals Corp., Labeling Revision
  • Cipro In Dextrose 5% in Plastic Container (ciprofloxacin) Injection, Bayer Pharmaceuticals Corp., Labeling Revision
  • Cipro XR (ciprofloxacin and ciprofloxacin hydrochloride) Extended-Release Tablets, Bayer Pharmaceuticals Corp., Labeling Revision
  • Flo-Pred (prednisolone acetate) Oral Suspension, Taro Pharmaceuticals, USA, Inc., Package Change
  • Kaletra (lopinavir and ritonavir) Oral Solution, Abbott Laboratories, Labeling Revision
  • Kaletra (lopinavir and ritonavir) Tablets, Abbott Laboratories, Labeling Revision
  • Olmesartan Medoxomil and Hydrochlorothiazide Tablets, Mylan Pharmaceuticals Inc., Tentative Approval
  • Primidone Tablets, Dr. Reddy's Laboratories, Ltd., Approval
  • Relenza (zanamivir) Inhalation Powder, GlaxoSmithKline, Labeling Revision
• Warning Letter: YAZ (drospirenone and ethinyl estradiol) Tablets

October 6, 2008

• Emergency Use Authorization (EUA) for the Pre-Event Provision and Potential Use of Doxycycline Hyclate Tablet Emergency Kits for Inhalational Anthrax
• Inactive Ingredient Database (updated)
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• New and Generic Drug Approvals
  • Bromocriptine Mesylate Tablets, Paddock Laboratories, Inc., Approval
  • Exjade (deferasirox) Oral Suspension Tablets, Novartis Pharmaceuticals Corp., Labeling Revision
  • Galantamine Hydrobromide Extended-release Capsules , Barr Laboratories, Inc., Approval
  • Hylenex[rDNA origin] (hyaluronidase [rDNA origin]) Injection, Halozyme Therapeutics Inc., Labeling Revision
  • Nitrolingual (nitroglycerin) Spray, Sciele Pharma, Inc., Package Change

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October 10, 2008 Federal Register: General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting.   October 9, 2008 Federal Register: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Recall Regulations    October 8, 2008 Federal Register: Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees Federal Register: Medical Devices; Hearing Aids; Technical Data Amendments; Confirmation of Effective Date   October 7, 2008 Summary Information for: Hoya iSpheric Model YA-60BB Intraocular Lens Summary Information for: XIENCE V Everolimus Eluting Coronary Stent System and PROMUS Everolimus Eluting Coronary Stent System   October 6, 2008 CDRH Learn   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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