• FDA issues an Early Communication about an Ongoing Safety Review for Botox and Botox Cosmetic (Botulinum toxin Type A) and Myobloc (Botulinum toxin Type B).

February 7, 2008

• Adverse Event Reporting System (AERS) Latest Quarterly Data Files
• Drug to be Discontinued: Humatin (Paromomycin Sulfate Capsules, USP)
• On February 6, FDA approved the first generic versions of Fosamax (alendronate sodium tablets), used to treat osteoporosis.
• New and Generic Drug Approvals
  • Alendronate Sodium Tablets, Teva Pharma, Approval
  • Alendronate Sodium Tablets, Barr Labs, Approval
  • Cefuroxime Axetil Oral Suspension, Ranbaxy, Approval
  • Daytrana (methylphenidate) Transdermal System, Shire Development, Labeling Revision
  • Esomeprazole Magnesium Delayed-Release Capsules, Ranbaxy Labs, Tentative Approval
  • Imodium Advanced (loperamide HCl and simethicone) Tablets, McNeil Consumer Healthcare, Labeling Revision
  • MoviPrep Oral solution, Salix Pharma, Labeling Revision
  • VFEND (voriconazole) Tablets, Pfizer Inc., Labeling Revision
  • VFEND I.V. (voriconazole) Injection, Pfizer Inc., Labeling Revision
  • VFEND (voriconazole) Oral Suspension, Pfizer Inc., Labeling Revision
  • Xopenex HFA (levalbuterol tartrate) Inhalation Aerosol, Sepracor Inc., Control Supp.

February 6, 2008

• CDER Organization Charts [HTML] [PDF] (updated)
• Drugs@FDA Downloadable Data Files (updated)
• FDA takes action to stop the marketing of unapproved injectable drugs containing colchicine.

February 5, 2008

• Division of Scientific Investigations, Office of Compliance: Contact DSI (updated)
• Drug Shortage: Resolved; Tikosyn (0.5mg and 0.25mg capsules)
• New and Generic Drug Approvals
  • Atazanavir Sulfate Capsules, Emcure Pharma, Tentative Approval
  • Chlor-Trimeton Allergy (chlorpheniramine maleate) Extended Release Tablets, Schering-Plough, Labeling Revision
  • Corgard (nadolol) Tablets, King Pharma, Labeling Revision
  • DISKETS Dispersible Tablets (methadone hydrochloride), Roxane Labs, Labeling Revision
  • EPIVIR (lamivudine) Scored Tablets, GlaxoSmithKline, Patient Population Altered
  • Methadose Oral Concentrate (methadone hydrochloride) Oral Concentrate, and Methadose Sugar-Free Oral, Mallinckrodt Inc., Labeling Revision
  • Remodulin (treprostinil sodium) Injection, United Therapeutics, Labeling Revision
  • Xyzal (levocetirizine dihydrochloride) Tablets, UCB, Inc., Labeling Revision

February 4, 2008

• New and Generic Drug Approvals
  • ALESSE (levonorgestrel and ethinyl estradiol) Tablets, Wyeth Pharma, Labeling Revision
  • Amlodipine Besylate Tablets, Mutual Pharma, Approval 
  • Caffeine Citrate Oral Solution, Abraxis Pharma, Approval 
  • Fluoxetine Capsules, Aurobindo Pharma, Approval  
  • Gabapentin Capsules, Aurobindo Pharma, Approval  
  • Irinotecan Hydrochloride Injection, Teva Parenteral, Tentative Approval 
  • Propranolol Hydrochloride Injection, Hikma Farmaceutica, Approval  
  • Sertraline Hydrochloride Tablets, Mylan Pharma, Approval 
• Standard Costs for Components of the Process for the Review of Human Drug Applications [HTML] [PDF]

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February 8, 2008 Federal Register: Devices: General Hospital and Personal Use Devices; Reclassification of Medical Device Data System FDA / NHLBI / NSF Workshop on Computer Methods for Cardiovascular Devices, March 18-19, 2008   February 7, 2008 FDA Clears for Market First Decellularized Heart Valve Medical Device Safety Article: Prevent life-threatening communication breakdowns Federal Register: Radiological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting.   February 5, 2008 Federal Register: Agency Information Collection Activities; Proposed Collection; Comment Request; Additional Listing Information for Medical Device Registration and Listing. Federal Register: Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Device Tracking. Federal Register: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Application for Participation in the Medical Device Fellowship Program. FDA Approves Drug-Eluting Stent for Clogged Heart Arteries Summary Information for: SJM Epic Valve and SJM Epic Supra Valve   February 4, 2008 Class I Medical Device Recall: Medtronic Inc. SynchroMed EL Implantable, Infusion Pump

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