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Center for Drug Evaluation &
Research (CDER) News

• Drug Shortages: Current Drug Shortage: Dexrazoxane for Injection, Zinecard
• New and Generic Drug Approvals
  • Actoplus Met XR (pioglitazone hydrochloride and metformin hydrochloride) Extended-Release Tablets, Takeda Global Research & Development Center, Inc., Approval
  • Azor (amlodipine besylate and olmesartan medoxomil) Tablets, Daiichi Sankyo Pharma Development, New or Modified Indication
  • Kerlone (betaxolol hydrochloride) Tablets, Sanofi-aventis, US, LLC, Labeling Revision
  • Lamictal (lamotrigine) Orally Disintegrating Tablets, GlaxoSmithKline, Approval
    Lamictal (lamotrigine) Tablets, GlaxoSmithKline, Labeling Revision
  • Lamictal (lamotrigine) Chewable Tablets, GlaxoSmithKline, Labeling Revision
  • Lotrisone (clotrimazole and betamethasone dipropionate) Lotion, Schering-Plough, Labeling Revision
  • Lotrisone (clotrimazole and betamethasone dipropionate) Cream, Schering-Plough, Labeling Revision
  • Tyzeka (telbivudine) Tablet, Novartis Pharmaceuticals Corp., Labeling Revision

May 14, 2009

• Drug Shortages: Current Drug Shortage: Oxycodone Immediate Release Tablets (5mg, 15mg and 30mg) (updated)

May 13, 2009

• Approved Drug Products with Therapeutic Equivalence Evaluations Orange Book (updated)
• Best Pharmaceuticals for Children Act of 2007: List of Determinations Including Written Request (updated)
• Drug Shortages: Resolved Drug Shortage: Fentanyl transdermal patch (updated)
• Memorandum of Meeting Minutes: Drug Safety Oversight Board Meeting, Public Summaries, April 16, 2009
• New and Generic Drug Approvals
  • Alfuzosin Hydrochloride Extended-Release Tablets, Sun Pharma Global Inc., Tentative Approval
  • Azasite (azithromycin) Ophthalmic Solution, Inspire Pharmaceuticals, Inc., Labeling Revision and Package Change
  • Combivent (albuterol sulfate and ipratropium bromide) Inhalation Aerosol, Boehringer Ingelheim Pharmaceuticals, Inc, Labeling Revision
  • Cycloset (bromocriptine mesylate) Tablets, VeroScience, LLC, Approval
  • Divalproex Sodium Extended-Release Tablets, Impax Laboratories, Inc., Approval
  • Fanapt (iloperidone) Tablets, Vanda Pharmaceuticals, Approval
• Office of Generic Drugs: April First-Time Generic Drug Approvals

May 12, 2009

• The Adverse Event Reporting System (AERS) Latest Quarterly Data Files
• Guidance for Industry: Labeling OTC Human Drug Products; Small Entity Compliance Guide [PDF]
• New and Generic Drug Approvals
  • Lamivudine and Zidovudine Tablets, Hetero Drugs Ltd. Unit III, Tentative Approval
  • Levemir (insulin detemir [rDNA origin]) Subcutaneous Injection, Novo Nordisk Inc., Labeling Revision
  • Meridia (sibutramine hydrochloride) Capsules, Abbott Laboratories, Labeling Revision
  • Mycophenolate Mofetil Tablets, Mylan Pharmaceuticals Inc., Approval
  • Mycophenolate Mofetil Capsules, Accord Healthcare, Inc., Approval
  • Mycophenolate Mofetil Capsules, Teva Pharmaceuticals USA, Approval
  • Mycophenolate Mofetil Tablets, Teva Pharmaceuticals USA, Approval
  • Mycophenolate Mofetil Tablets, Zydus Pharmaceuticals USA Inc., Approval
  • Mysoline (primidone) Tablets, Valeant Pharmaceuticals International, Manufacturing Change or Addition
  • Nicorette (nicotine polacrilex) Gum, GlaxoSmithKline Consumer Healthcare, Efficacy Supplement with Clinical Data to Support
  • Nicorette (nicotine polacrilex) Gum, GlaxoSmithKline Consumer Healthcare, Efficacy Supplement with Clinical Data to Support
  • Novolog (insulin aspart [rDNA origin]) Subcutaneous Injection, Novo Nordisk Inc., Labeling Revision
  • Novolog Mix 70/30 (insulin aspart protamine suspension and insulin aspart [rDNA origin]), Novo Nordisk Inc., Labeling Revision
  • Plavix (clopidogrel bisulfate) Tablets, Sanofi-Aventis U.S. Inc., Labeling Revision
  • Proquin XR (ciprofloxacin hydrochloride) Extended-Release Tablets, DepoMed, Inc., Labeling Revision
  • Sumatriptan Succinate Tablets, Orchid Healthcare, Tentative Approval
  • Sumatriptan Succinate Tablets, Sandoz Inc., Tentative Approval

May 11, 2009

• Best Pharmaceuticals for Children Act of 2007: List of Determinations Including Written Request (updated)
• Drug Shortages: Current Drug Shortage: Cisplatin Injection 1mg/ml (updated)
• Drug Shortages: Current Drug Shortage: Oxycodone Immediate Release Tablets (5mg, 15mg and 30mg) (updated)
• Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies (updated)
• BPCA/Pediatric Exclusivity Statistics (updated)

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