• FDA approves iobenguane I 123 injection (AdreView, GE Healthcare), a diagnostic radiopharmaceutical, for use in the detection of primary or metastatic pheochromocytoma or neuroblastoma as an adjunct to other diagnostic tests. Prescribing Information.
• New and Generic Drug Approvals
  • Carbidopa and Levodopa Orally Disintegrating Tablets, Mylan Pharmaceuticals, Inc., Approval
  • Celexa (citalopram hydrobromide) Oral Solution, Forest Laboratories, Inc., Labeling Revision
  • Celexa (citalopram hydrobromide) Tablets, Forest Laboratories, Inc., Labeling Revision
  • Epirubicin Hydrochloride Injection, Activis Totowa, LLC, Approval
  • Lexapro (escitalopram oxalate) Oral Solution, Forest Laboratories, Inc., Labeling Revision 
  • Lexapro (escitalopram oxalate) Tablets, Forest Laboratories, Inc., Labeling Revision
  • Ziprasidone Hydrochloride Capsules, Sandoz, Inc., Tentative Approval

September 18, 2008

• Covidien and Mallinckrodt Inc. inform healthcare professionals of important new safety information in prescribing Phosphocol P 32. MedWatch Safety Information
• Drug Shortages: Current Drug Shortages; Ammonul (sodium phenylacetate and sodium benzoate) Injection 10%/10%
• Drugs Shortages: Drugs to be Discontinued: Mitozytrex (Mitomycin for Injection)
• FDA releases its fourth issue of the FDA Drug Safety Newsletter
• International Conference on Harmonization (ICH) Public Meeting, October 21, 2008, Rockville, Maryland: Meeting information and registration
• List of Drugs Manufactured at the Dewas and Paonta Sahib Facilities of Ranbaxy Laboratories, Ltd. (updated)
• New and Generic Drug Approvals
  • Amiodarone Hydrochloride Tablets, Zydus Pharmaceuticals USA Inc., Approval
  • Glucovance (glyburide and metformin hydrochloride) Tablets, Bristol-Myers Squibb Co., Labeling Revision
  • Keflex (cephalexin) Capsules, MiddleBrook Pharmaceuticals, Labeling Revision
  • Proair HFA (albuterol sulfate) Inhalation Aerosol, Teva Global Regulatory Research, LLC, Patient Population Altered
  • Protriptyline Hydrochloride Tablets, Roxane Laboratories, Inc., Approval

September 17, 2008

• Drugs@FDA Downloadable Data Files (updated)
• Guidance for Industry: S1C(R) Guidance on Dose Selection for Carcinogenicity Studies of Pharmaceuticals [PDF]
• New and Generic Drug Approvals
  • Galantamine Hydrobromide Extended-Release Capsules, Barr Laboratories, Inc., Approval
  • Lybrel (levonorgestrel and ethinyl estradiol) Tablets, Wyeth Pharmaceuticals, Inc., Labeling Revision
  • Risperidone Tablets, Apotex Corp., Approval
  • Risperidone Tablets, Mylan Pharmaceuticals, Inc., Approval

September 16, 2008

• FDA Issues Warning Letters to Ranbaxy Laboratories Ltd., and an Import Alert for Drugs from Two Ranbaxy Plants in India. Drug Information.
• Meetings of the Nonprescription Drugs Advisory Committee (NDAC) (updated)
• New and Generic Drug Approvals
  • Hydralazine Hydrochloride Tablets, Hetero Drugs, Ltd., Approval
  • Keppra XR (levetiracetam) Extended-Release Tablets, UCB, Inc., Approval
  • Lamivudine and Tenofovir Disoproxil Fumarate Tablets, Matrix Laboratories, Ltd., Tentative Approval
  • Remodulin (treprostinil sodium) Subcutaneous I.V. Injection, United Therapeutics Corp., Labeling Revision
  • Sancuso (granisetron) Transdermal System, Strakan International, Ltd., Approval
  • Tarceva (erlotinib hydrochloride) Tablets, OSI Pharmaceuticals, Inc., Labeling Revision
• Rulemaking History for OTC Sunscreen Drug Products: Time and Extent Applications (updated)

September 15, 2008

• New and Generic Drug Approvals
  • Alendronate Sodium Tablets, Sun Pharmaceutical Industries, Ltd., Approval
  • Detrol (tolterodine tartrate) Tablets, Pfizer Global Pharmaceuticals, Labeling Revision
  • Detrol LA (tolterodine tartrate) Extended-Release Capsules, Pfizer Global Pharmaceuticals, Labeling Revision
  • Galantamine Hydrobromide Tablets, Dr. Reddy's Laboratories, Ltd., Approval
  • NeoProfen (ibuprofen lysine) Intravenous Injection, Ovation Pharmaceuticals, Inc., Labeling Revision
  • Potassium Chloride 0.149% in Sodium Chloride 0.45% in Plastic Container (potassium chloride and sodium chloride) Injection, Hospira Inc., Approval
  • Remodulin (treprostinil sodium) Subcutaneous I.V. Injection, United Therapeutics Corp., Labeling Revision
  • Stromectol (ivermectin) Tablets, Merck & Co., Inc., Labeling Revision

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September 19, 2008 Summary Information for: Akreos Posterior Chamber Intraocular Lens Federal Register: Draft Guidance for Industry and Food and Drug Administration Staff; Clinical Investigations of Devices Indicated for the Treatment of Urinary Incontinence; Availability   September 18, 2008 Draft Guidance for Industry and FDA Staff - Clinical Investigations of Devices Indicated for the Treatment of Urinary Incontinence Maturity Health Matters: FDA Health News for Older Adults and Their Caregivers (Fall 2008 Issue)   September 17, 2008 Federal Register: Medical Devices; Medical Device Reporting; Baseline Reports; Confirmation of Effective Date   September 16, 2008 Guidance for Industry and FDA Staff - Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers   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: • Possible Malfunction of Electronic Medical Devices Caused by Computed Tomography (CT) Scanning • Life-threatening Complications Associated with Recombinant Human Bone Morphogenetic Protein in Cervical Spine Fusion Class I Medical Device Recalls - • Pacific Consolidated Industries LLC, Mobile Oxygen Storage Tank • Boston Scientific NexStent Monorail, NexStent Carotid Stent and Monorail Delivery System • Levitronix CentriMag Extracorporeal Blood Pumping System; CentriMag Primary Console (with v200 Application Software On Board) FDA Patient

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