• Clarification of Recent FDA Initiatives Affecting OTC Drugs
• Drug Master Files (updated)
• New and Generic Drug Approvals
  • Accretropin (somatropin [Rdna origin]) Injection, Cangene Corp, Approval
  • Moxatag (amoxicillin extended-release) Tablet, MiddleBrook Pharma, Approval
  • Oxytocin Injection, Teva Parenteral, Approval
• FDA issues an Early Communication about an Ongoing Data Review for Ezetimibe/Simvastatin (marketed as Vytorin), Ezetimibe (marketed as Zetia), and Simvastatin (marketed as Zocor). FDA Statement

January 24, 2008

• Bayer and FDA inform healthcare professionals of the market withdrawal of the current liquid formulation of Leukine (sargramostim). MedWatch Information
• Drug Shortages
  • Resolved Drug Shortage: A-methapred (methylprednisolone sodium succinate) for injection
  • Resolved Drug Shortage: Cyclophosphamide
• New and Generic Drug Approvals
  • Azactam (aztreonam) Injection, Bristol-Myers, Labeling Revision
  • Azactam (aztreonam) Intravenous Injection, Bristol-Myers, Labeling Revision
  • MYCAMINE  (micafungin sodium) Injection, Astellas Pharma, New or Modified Indication
  • Tolectin DS (tolmetin sodium) Capsules, Ortho McNeil, Labeling Revision
  • Tolectin 600 (tolmetin sodium) Tablets, Ortho McNeil, Labeling Revision

January 23, 2008

• Guidance for Industry: Guidance Agenda: Guidances CDER is Planning to Develop During Calendar Year 2008
• Drug Shortages
  • Current Drug Shortage: Leukine (sargramostim) liquid 500 mcg vial containing EDTA
  • Resolved Drug Shortage: Amytal (amobarbital sodium) injection Company Information
• Drugs@FDA Downloadable Data Files (updated)
• New and Generic Drug Approvals
  • CIPRO XR (ciprofloxacin extended-release) Tablets, Bayer Pharma, Labeling Revision
  • CIPRO (ciprofloxacin hydrochloride) Tablets, Bayer Pharma, Labeling Revision
  • CIPRO (ciprofloxacin hydrochloride) Oral Suspension, Bayer Pharma, Labeling Revision
  • CIPRO (ciprofloxacin hydrochloride) Intravenous Solution, Bayer Pharma, Labeling Revision
  • Intelence (etravirine) Tablets, Tibotec Inc., Approval
  • Lansoprazole Delayed-release Capsules, Teva Pharma, Tentative Approval
  • Prilosec OTC (omeprazole magnesium) Delayed-Release Tablets, Proctor & Gamble, Labeling Revision
  • Tekturna HCT (aliskiren/hydrochlorothiazide) Tablets, Novartis Pharma, Approval
  • WelChol (colesevelam hydrochloride) Tablets, Daiichi Sankyo, New or Modified Indication
• Warning Letter: Inspection, Tomita Pharmaceutical Co., Ltd

January 22, 2008

• FDA approves additional changes to the Ortho Evra Contraceptive Transdermal (Skin) Patch label.

CDER Drug Links

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January 25, 2008
	Class I Medical Device Recall: Cordis Corporation Dura Star RX and Fire Star RX PTCA Balloon Catheters
January 24, 2008
	PMA Final Decisions for December 2007

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