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Summaries of Medical and Clinical Pharmacology Reviews
 of Pediatric Studies
as of January 15, 2008

Total Number of Drugs with Summaries Posted: 88

Summaries of Medical and Clinical Pharmacology Reviews

Drug Sponsor Review Summary
Alendronate - Fosamax Merck Medical PDF document Clinical Pharmacology PDF document
Amphetamines - Adderall XR Shire Medical PDF document Clinical Pharmacology PDF document
Anagrelide - Agrylin Shire Medical PDF document Clinical Pharmacology PDF document
Argatroban - Argatroban Encysive Medical PDF document Clinical Pharmacology PDF document
Aripiprazole - Abilify Otsuka Medical PDF document Clinical Pharmacology PDF document
Atovaquone and Proguanil - 
  Malarone 
GlaxoSmithKline Medical PDF document Clinical Pharmacology PDF document
Balsalazide - Colazal Salix Pharmaceuticals, Inc. Medical PDF document Clinical Pharmacology PDF document
Benazepril - Lotensin Novartis Medical PDF document Clinical Pharmacology PDF document
Betaxolol - Betoptic Alcon Medical PDF document None*
Brinzolamide - Azopt Alcon Medical PDF document None*
Budesonide - Pulmicort AstraZeneca Medical PDF document None*
Carboplatin - Paraplatin Bristol-Myers Squibb Medical PDF document Clinical Pharmacology PDF document
Carvedilol - Coreg GlaxoSmithKline Medical PDF document Clinical Pharmacology PDF document
Celecoxib - Celebrex G.D. Searle Medical PDF document Clinical Pharmacology PDF document
Ciprofloxacin - Ciloxan Alcon Medical PDF document None*
Ciprofloxacin - Cipro Bayer Medical PDF document Clinical Pharmacology PDF document
Citalopram - Celexa Forest Labs Medical PDF document Clinical Pharmacology PDF document
Clofarabine - Clolar Ilex Medical PDF document Clinical Pharmacology PDF document
Desflurane - Suprane Baxter Healthcare Corporation Medical PDF document None*
Dorzolamide - Trusopt Merck Medical PDF document None*
Emtricitabine - Emtriva Gilead Sciences Medical PDF document
Medical PDF document
Clinical Pharmacology PDF document
Ertapenem - Invanz Merck Medical PDF document Clinical Pharmacology PDF document
Esmolol - Brevibloc Baxter Medical PDF document Clinical Pharmacology PDF document
Fenoldopam - Corlopam Abbott Medical PDF document Clinical Pharmacology PDF document
Fentanyl - Duragesic ALZA Medical PDF document Clinical Pharmacology PDF document
Fentanyl - Actiq Cephalon, Inc. Medical PDF document Clinical Pharmacology PDF document
Fexofenadine - Allegra Aventis Medical PDF document Clinical Pharmacology PDF document
Fluconazole - Diflucan Pfizer Medical PDF document Clinical Pharmacology PDF document
Fludarabine - Fludara Berlex Medical PDF document Clinical Pharmacology PDF document
Fluticasone - Flonase GlaxoSmithKline Medical PDF document None*
Fluticasone - Flovent GlaxoSmithKline Medical PDF document Clinical Pharmacology PDF document
Fluvastatin - Lescol Novartis Medical PDF document None*
Fosinopril - Monopril Bristol-Myers Squibb Medical PDF document Clinical Pharmacology PDF document 
Gemcitabine - Gemzar Lilly Medical PDF document None*
Glimepiride - Amaryl Aventis Medical PDF document Clinical Pharmacology PDF document 
Glyburide and Metformin - 
  Glucovance 
Bristol-Myers Squibb Medical PDF document Clinical Pharmacology PDF document 
Imatinib - Gleevec Novartis Medical PDF document Clinical Pharmacology PDF document
Imiquimod - Aldara 3M Medical PDF document Clinical Pharmacology PDF document
Insulin aspart - NovoLog Novo Nordisk Medical PDF document None*
Irbesartan - Avapro Sanofi-Synthelabo Medical PDF document Clinical Pharmacology PDF document
Irinotecan - CAMPTOSAR Pfizer Medical PDF document Clinical Pharmacology PDF document
Lamotrigine - Lamictal GlaxoSmithKline Medical PDF document Clinical Pharmacology PDF document
Lansoprazole - Prevacid TAP Medical PDF document Clinical Pharmacology PDF document 
Leflunomide - Arava Aventis Medical PDF document Clinical Pharmacology PDF document
Levofloxacin - Levaquin Johnson & Johnson Medical PDF document Clinical Pharmacology PDF document
Levetiracetam - Keppra UCB Medical PDF document Clinical Pharmacology PDF document
Levobetaxolol - Betaxon Alcon Medical PDF document None*
Linezolid - Zyvox Pfizer Medical PDF document Clinical Pharmacology PDF document
Meloxicam - Mobic Boehringer Ingelheim Medical PDF document Clinical Pharmacology PDF document
Methylphenidate - Concerta McNeil Medical PDF document Clinical Pharmacology PDF document
Metoprolol - Toprol-XL AstraZeneca Medical PDF document Clinical Pharmacology PDF document
Mirtazapine - Remeron Organon Medical PDF document Clinical Pharmacology PDF document
Modafinil - Provigil Cephalon Medical PDF document Clinical Pharmacology PDF document
Nefazodone - Serzone Bristol-Myers Squibb Medical PDF document Clinical Pharmacology PDF document
Nelfinavir - Viracept Agouron Medical PDF document Clinical Pharmacology PDF document
Norgestimate and Ethinyl Estradiol - 
  ORTHO TRI-CYCLEN
Johnson & Johnson Medical PDF document
Medical PDF document
Clinical Pharmacology PDF document
Octreotide - Sandostatin LAR Novartis Medical PDF document Clinical Pharmacology PDF document
Olanzapine - Zyprexa Eli Lilly Medical PDF document Clinical Pharmacology PDF document
Ondansetron - Zofran GlaxoSmithKline Medical PDF document Clinical Pharmacology PDF document
Ofloxacin - Ocuflox Allergan Medical PDF document None*
Orlistat - Xenical Hoffmann-La Roche Medical PDF document Clinical Pharmacology PDF document
Oseltamivir - Tamiflu Roche Medical PDF document Clinical Pharmacology PDF document
Oxaliplatin - Eloxatin Sanofi-Aventis US Inc. Medical PDF document Clinical Pharmacology PDF document
Oxcarbazepine - Trileptal Novartis Medical PDF document Clinical Pharmacology PDF document
Oxybutynin - Ditropan Johnson & Johnson Medical PDF document Clinical Pharmacology PDF document
Paricalcitol - Zemplar Abbott Medical PDF document None*
Paroxetine - Paxil GlaxoSmithKline Medical PDF document Clinical Pharmacology PDF document
Ramipril - Altace King Medical PDF document Clinical Pharmacology PDF document
Risperidone - Risperdal Johnson and Johnson Medical PDF document Clinical Pharmacology PDF document
Ritonavir - Norvir Abbott Medical PDF document Clinical Pharmacology PDF document
Rofecoxib - Vioxx Merck Medical PDF document Clinical Pharmacology PDF document
Rosiglitazone - Avandia GlaxoSmithKline Medical PDF document Clinical Pharmacology PDF document
Salmeterol - Serevent GlaxoSmithKline Medical PDF document None*
Sertraline - Zoloft Pfizer Medical PDF document None*
Sibutramine - Meridia Abbott Medical PDF document Clinical Pharmacology PDF document
Sirolimus - Rapamune Wyeth Medical PDF document Clinical Pharmacology PDF document
Sodium Ferric Gluconate - Ferrlecit Watson Medical PDF document Clinical Pharmacology PDF document
Sumatriptan - Imitrex GlaxoSmithKline Medical PDF document Clinical Pharmacology PDF document
Temozolomide - Temodar Schering Medical PDF document Clinical Pharmacology PDF document
Testosterone gel 1 % - AndroGel New!! 12/14/2007 Solvay Pharmaceuticals Medical PDF document Clinical Pharmacology PDF document
Timolol - Timolol GFS Alcon Research Medical PDF document None*
Tolterodine - Detrol and Detrol LA Pfizer Medical PDF document Clinical Pharmacology PDF document
Topotecan - Hycamtin GlaxoSmithKline Medical PDF document Clinical Pharmacology PDF document
Valsartan - Diovan New!! 12/14/2007 Novartis Medical PDF document Clinical Pharmacology PDF document
Venlafaxine - Effexor Wyeth Ayerst Medical PDF document Clinical Pharmacology PDF document
Zolmitriptan - Zomig AstraZeneca Medical PDF document Clinical Pharmacology PDF document
Zolpidem - Ambien Sanofi Aventis Medical PDF document Clinical Pharmacology PDF document

*  No clinical pharmacology review was conducted for this drug.    back to top of table

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Date created: June 18, 2003;  Last updated: January 15, 2008

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