• Drug Development and Drug Interactions (updated)
• Drug Safety Oversight Board Meeting, September 18, 2008, Public Summary

October 2, 2008

• Drugs@FDA Downloadable Data Files (updated)
• Guidance for Industry: Comprehensive List of Guidance Documents
• Guidance for Industry: New/Revised/Withdrawn List for 2008
• Investigational Human Drugs: Clinical Investigator Inspection List (updated)
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• New and Generic Drug Approvals
  • Curosurf (poractant alpha) Intratracheal Suspension, Dey, L.P., Labeling Revision
  • Didanosine Delayed-Release Capsules, Aurobindo Pharma, Approval
  • EpiPen and Epi E Z Pen Jr (epinephrine) Intramuscular Injection, Meridian Medical Technologies Inc., Labeling Revision
  • Exubera (insulin human [rDNA origin]) Inhalation Powder, Labeling Revision
  • Reyataz (atazanavir sulfate) Capsules, Bristol-Myers Squibb Co., Patient Population Altered
  • Videx Ec (didanosine) Delayed Release Capsules, Bristol-Myers Squibb Co., Patient Population Altered
• Warning Letter: Mirapex (pramipexole dihydrochloride)

October 1, 2008

• Best Pharmaceuticals for Children Act of 2007: List of Determinations Including Written Request (updated)
• Drugs Shortages: Drugs to be Discontinued: SecreFlo (porcine secretin for injection, 16 mcg/vial) (updated)
• New and Generic Drug Approvals
  • Cyclobenzaprine Hydrochloride Tablets, Aurobindo Pharma USA, Inc., Approval
  • Gleevec (imatinib mesylate) Tablets, Novartis Pharmaceuticals Corp., Labeling Revision
  • Promethazine Hydrochloride Injection, Wockhardt USA, Inc., Approval
  • Stalevo (carbidopa and entacapone and levodopa) Tablets, Orion Corp., Labeling Revision
  • Tramadol Hydrochloride and Acetaminophen Tablets, Alphapharm Party, Ltd., Approval
• Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies (updated)
• Paragraph IV Patent Certifications (updated)

September 30, 2008

• New and Generic Drug Approvals
  • Adagen (pegademase bovine) Injection, Enzon Pharmaceuticals, Inc., Labeling Revision
  • Alfuzosin Hydrochloride Extended-Release Tablets, Mylan Pharmaceuticals Inc., Tentative Approval
  • Alprazolam Tablets, Vintage Pharmaceuticals, LLC, Approval
  • Capoten (captopril) Tablets, Par Pharmaceutical, Inc., Labeling Revision
  • Exubera (insulin [rDNA origin]) Inhalation Powder, Pfizer Inc., Labeling Revision
  • Hydroxyzine Hydrochloride Tablets, Amneal Pharmaceuticals, Approval
  • Moexipril Hydrochloride and Hydrochlorothiazide Tablets, Paddock Laboratories, Inc., Approval
  • Tamiflu (oseltamivir phosphate) Capsules, Hoffmann-La Roche, Inc., Labeling Revision
  • Vaseretic (enalapril maleate and hydrochlorothiazide) Tablets, Biovail Laboratories International SRL, Labeling Revision
  • Vasotec (enalapril maleate) Tablets, Biovail Laboratories International SRL, Labeling Revision

September 29, 2008

• Drug Development and Drug Interactions: Meetings: FDA Critical Path Transporter Workshop - (updated)
• On September 26th, FDA approves Alimta (pemetrexed) injection for use in combination with cisplatin therapy for the initial treatment of patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC). Prescribing Information
• Public Hearing for Over-the-Counter Cough and Cold Medications, October 2, 2008, Beltsville, Maryland: Meeting information and registration - (updated)

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October 3, 2008 Class I Medical Device Recall: Nebion, LLC HLX-8 Magnetic Resonance Device   October 2, 2008 Consumer Information on: Akreos Posterior Chamber Intraocular Lens - P060022 Consumer Information on: COBAS TaqMan HBV Test For Use With The High Pure System - P050028 Consumer Information on: Hoya iSpheric Model YA-60BB Intraocular Lens - P080004   October 1, 2008 Class I Medical Device Recall: Medtronic Neuromodulation INDURA One-Piece (IP) Intrathecal Catheters, Sutureless Pump Connector Revision Kit, and Intrathecal Catheter Pump Segment Revision Kit Ophthalmic Devices Panel Advisory Meeting, June 10, 2008 - Written Comments Registration and Listing (Device Establishment Registration and Listing for FY2009 Now Available)   September 29, 2008 Electronic Copies for Pre-Market Submissions (Updated 09/08)   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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