December 4, 2009

• BPCA/Pediatric Exclusivity Statistics:
  • Pediatric Exclusivity Statistics (updated)
  • Written Requests Issued (updated)

December 3, 2009

• Drugs@FDA Download File (updated)
• Drug Shortages: Drugs to be Discontinued: Humulin 50/50 Insulin (updated)
• FDA Approves Kalbitor for Treating Potentially Life-Threatening Attacks of Hereditary Angioedema
• FDA Drug Safety Newsletter - Volume 2, Number 3, 2009
• Guidance for Industry: Assay Development for Immunogenicity Testing of Therapeutic Proteins (PDF - 161 KB)
• Information for Healthcare Professionals: Risk of Neural Tube Birth Defects following prenatal exposure to Valproate
• Medication Guides (updated)

December 2, 2009

• Drug Shortages: Current Drug Shortages: Erythromycin Ophthalmic Ointment (updated)
• Drug Shortages: Current Drug Shortages: Fabrazyme (agalsidase beta) (updated)
• Drug Shortages: Current Drug Shortages: Technetium Tc99m Generators (updated)
• MedWatch Alert for Norpramin (desipramine hydrochloride)
• Guidance for Industry: 
  • Comprehensive List of Guidance Documents (PDF - 698 KB)  (updated 12/1/2009)

  • New/Revised/Withdrawn List for 2009 (PDF - 116 KB)  (12/1/2009)

• National Drug Code Directory (updated)

November 30, 2009

• FDA’s Woodcock Discusses Pain Management and Drug Safety in Nov. 26, 2009 Issue of The New England Journal of Medicine
• Guidance for Industry: Newly added Individual Product Bioequivalence Recommendations

December 3, 2009

• Adrenaclick (epinephrine injection) Single-Dose Auto-Injector, Sciele Pharma, Inc., Manufacturing Change or Addition
• Kalbitor (ecallantide) Injection, Dyax Corporation, Approval 
• ORTHO EVRA (norelgestromin and ethinyl estradiol) Patch, Johnson & Johnson Pharmaceuticals Research & Development, Labeling Revision
• Patanase (olopatadine hydrochloride) Nasal Spray, Alcon Research, Ltd., Efficacy Supp. w/Clinical Data
• Xenazine (tetrabenazine) Tablets, Biovail Americas Corporation, Labeling Revision
• Zegerid (omeprazole and sodium bicarbonate) Capsules, Schering-Plough Healthcare Products, Inc., Approval 

December 2, 2009

• Atomoxetine Hydrochloride Capsules, Mylan Pharmaceuticals, Inc., Tentative Approval
• Atomoxetine Hydrochloride Capsules, Sandoz Inc., Tentative Approval
• Atomoxetine Hydrochloride Capsules, Sun Pharma Global, Tentative Approval
• Atomoxetine Hydrochloride Capsules, TEVA Pharmaceuticals, Tentative Approval
• Ciclopirox Shampoo, Paddock Laboratories, Inc., Approval
• Divalproex Sodium Delayed-Release Tablets, Vintage Pharmaceuticals, LLC, Approval
• Glucovance (glyburide and metformin hydrochloride) Tablets, Bristol-Myers Squibb Co., Labeling Revision
• Intelence (etravirine) Tablets, Tibotec, Inc., Efficacy Supplement with Clinical Data to Support
• Methadone Hydrochloride Tablets, The PharmaNetwork LLC, Approval
• Nexcede (ketoprofen) Oral Soluble Film, Novartis Consumer Health, Inc., Approval
• Parnate (tranylcypromine sulfate) Tablets, GlaxoSmithKline, Labeling Revision
• Risperidone Orally Disintegrating Tablets, Dr. Reddy’s Laboratories Ltd., Chemistry New Strength 
• Urso 250 (ursodiol) Tablets, Axcan Scandipharm, Inc., Labeling Revision
• Urso Forte (ursodiol) Tablets, Axcan Scandipharm, Inc. Labeling Revision
• Vagifem (estradiol) Vaginal Tablets, Novo Nordisk Pharmaceuticals, Inc., Efficacy Suppement with Clinical Data to Support

December 1, 2009

• Avelox (moxifloxacin hydrochloride) Tablets, Bayer HealthCare Pharmaceuticals, Inc., Labeling Revision
• Aveloxin Sodium Chloride 0.8% in Plastic Container (moxifloxacin hydrochloride) I.V. Injection, Bayer HealthCare Pharmaceuticals, Inc., Labeling Revision
• Norvir (ritonavir) Capsules, Abbott Laboratories, Labeling Revision
• Norvir (ritonavir) Oral Solution, Abbott Laboratories, Labeling Revision