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Pediatric Advisory Committee Meetings

2004 | 2005 | 2006 | 2007

2007

• 11/27/07: Adverse Report Update: Tamiflu and Review of Neuropsychiatric Cases for: Relenza, Symmetrel, & Flumadine
  11/28/07: Adverse Event Reporting: Azopt, Betaxon, Emtrivia, Gleevec, Provigil and Serevent
  11/29/07: Clinical Lactation Studies—Study Design, Data Analysis, and Recommendations for Labeling
• 10/18-19/07: Joint Meeting of the Nonprescription Drugs Advisory Committee and the Pediatric Advisory Committee
• 4-11-07: Adverse Event Reporting: Lescol (fluvastatin), Sandostatin (octreotide)
• Adverse Event Reporting Update: Ditropan (oxybutynin chloride) and Xenical (orlistat)
• 4-12-07: Joint Anti-Infective Drugs Advisory Committee and the Pediatric Advisory Committee on Shiga toxin-producing bacteria

2006

• 11-29-2006: Joint Arthritis, Pediatric, and Drug Safety and Risk Management Advisory Committee on Celebrex for JRA
• 11-16-2006: Adverse Event Reporting: Amaryl (glimepiride), Avandia (rosiglitazone), Gemzar (gemcitabine), Invanz (ertapenem), Mobic (meloxicam), Norvir (ritonavir), Novolog (insulin aspart), Rapamune (sirolimus), Trileptal (oxcabazine), Zofran (ondansetron), Zyvox (linezolid)
• Adverse Event Reports Update: Celexa (citaopram), Ditropan (oxybutynin chloride), Lipitor (atorvastatin), Tamiflu (oseltamivir), Zocor (simvastatin)
• 3-22-2006: ADHD Medications: Psychiatric, neurological and cardiovascular adverse events
• Adverse Event Reporting: Amaryl (glimepiride), Avandia (rosiglitazone), Gemzar (gemcitabine), Invanz (ertapenem), Mobic (meloxicam), Norvir (ritonavir), Novolog (insulin aspart), Rapamune (sirolimus), Trileptal (oxcabazine), Zofran (ondansetron), Zyvox (linezolid)
• Adverse Event Reports Update: Celexa (citaopram), Ditropan (oxybutynin chloride), Lipitor (atorvastatin), Tamiflu (oseltamivir), Zocor (simvastatin)

2005

• 11/18/2005: Adverse Event Report: Agrylin (anagrelide), Paraplatin (carboplatin), Diflucan (fluconazole), Tamiflu (oseltamivir), Vioxx (rofecoxib)...
• 11/16-17/2005: Obesity Devices: Pediatric obesity, clinical trial designs for the evaluation of devices and ethical issues related to the evaluation of devices intended to treat pediatric obesity.
• 06/30/2005: Adverse Event Reporting: methylphendidate (Concerta and other methtylphenidates)
• 06/29/2005: Adverse Event Reporting: Ortho Tri-Cyclen (ethinyl estradiol, norgestimate), Cipro (ciprofloxacin), Detrol LA (tolterodine), Arava (leflunomide), Zemplar (paricalcitol) Zomig (zolmitriptan) Trusopt (dorzolamide)
• 02/15/2005: Possible Risk of Cancer From the Use of the Topical Immunosuppressant
• 02/14/2005: Adverse Event Reporting: Lotensin (benazepril), Xenical (orlistat), Brevobloc (esmolol), Malarone (atovaquone/proguanil), Viracept (nelfinavir), and Glucovance (glyburide/metformin)

2004

• 9/15/2004: Adverse Event Reporting: Pulmicort/Rhinocort (budesonide), Clarinex (desloratadine),Cutivate/Flonase/Flovent (fluticasone), Oculfox (ofloxacin), Fludara (fludarabine), and Fosamax (alendronate)
• 9/13-14/2004: Discussion of reports of the occurrence of suicidality in clinical trials for various antidepressant drugs in pediatric patients
  Docket No:2004N-0330

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FDA Office of Pediatric Therapeutics