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Pediatrics

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Spectrum of Diseases/Conditions
Written Requests

As of October 31, 2004

Cardiovascular
  • Hypertension
  • Pre-op Hypertension
  • Controlled Hypotension
  • Congestive Heart Failure
  • Tachyarrhythmia
  • Prevention of thrombosis in congenital heart disease surgically treated with shunts
  • Raynaud's Phenomenon
  • Primary pulmonary hypertension of the newborn
  • Post-surgical pulmonary hypertension
  • Primary or secondary pulmonary hypertension

Neurology

  • Depression
  • Partial Seizures
  • Generalized Seizures
  • Migraine
  • Obsessive Compulsive Disorder
  • General Anxiety Disorder
  • Multiple Sclerosis
  • Attention Deficit Hyperactivity Disorder
  • Adolescent Onset Schizophrenia
  • Adolescent Mania in association with Bipolar Disorder
  • Major Depressive Disorder (MDD)
  • Adolescent Onset Panic Disorder
  • Spasticity management
  • Excessive sleepiness in Obstructive Sleep Apnea (OSA)
  • Narcolepsy

Analgesics and Anesthetics

  • Mild Pain
  • Moderate - Severe Pain
  • Chronic Pain
  • Anesthesia
  • Sedation
  • Malignancy-related breakthrough pain

Gastroenterology

  • Reflux
  • Irritable Bowel Syndrome
  • Ulcers
  • Erosive Esophagitis
  • Prevention of post-operative nausea & vomiting
  • Treatment and prevention of nausea & vomiting associated with Emetogenic Chemotherapy
  • Ulcerative Colitis (UC)
  • Occasional Constipation
  • Gastroesophageal Reflux Disease (GERD)
  • Crohn's Disease
  • Acute Diarrhea

Hematology & Coagulation

  • Iron Deficiency in patients undergoing chronic hemodialysis
  • Thromboembolism
  • Thrombocythemia
  • Thrombocytopenia
  • Deep Vein Thrombosis  (DVT)

Dermatology

  • Oral mucositis
  • Aphthous ulcers
  • Cutaneous candidiasis
  • Atopic Dermatitis
  • Ichthyosis vulgaris
  • Tinea cruris
  • Tinea pedis
  • Steroid-responsive Dermatosis
  • Alopecia Areata
  • Tinea capitis
  • Molluscum Contagiosum

Oncology

  • Refractory or Relapsed CNS Leukemia and Lymphoma
  • Refractory or Relapsed Pediatric Malignancies
  • Allogeneic bone marrow transplants
  • Philadelphia Positive (Ph+) Leukemia
  • Mixed Lineage Acute Leukemia
  • Acute Lymphoblastic Leukemia
  • Acute Myelogenous Leukemia
  • Neuroblastoma
  • Brain tumors and other solid tumors
  • Hematologic tumors
  • Hodgkin's Disease
  • Non-Hodgkin's lymphomas
  • Sickle Cell Disease
  • Protection from toxicity in cancer patients
Endocrine
  • Familial Hypercholesterolemia
  • Type 1 Diabetes
  • Type 2 Diabetes
  • Renal Failure 2º Hyperparathyroidism
  • Obesity
  • Hypothalamic Obesity
  • McCune-Albright Syndrome
  • Failure to Thrive in AIDS Pediatric Patients
  • Osteogenesis Imperfecta (OI)
  • Bone Mineral Density in OI patients
  • Gynecomastia
  • Delayed puberty in boys with primary and secondary hypogonadism
  • Bone mineral density in anorexia nervosa patients
  • Testotoxicosis
  • Acromegalic Gigantism

Infections (not viral)

  • Complicated Urinary Tract Infection
  • Tuberculosis
  • Malaria
  • Candidiasis
  • Skin and Skin Structure
  • Bacterial Meningitis
  • CSF Shunt Infections
  • Recurrent Otitis Media and Otitis Media Treatment Failures
  • Community Acquired Pneumonia (CAP)
  • Bacteremic Pneumonia
  • Invasive Aspergillosis
  • Rare mold infections
  • H. Pylori
  • Resistant infections, or infections that do not respond to the first choice antibiotic

Antivirals

  • HIV
  • Herpes Simplex Virus (HSV)
  • Varicella Zoster Virus (VZV)
  • Hepatitis B
  • Hepatitis C
  • Influenza A & B
  • Cytomegalovirus (CMV Disease)

Immunomodulators

  • Renal Transplant
  • Immune Suppression

Ophthalmologic

  • Increased Intraocular Pressure
  • Neonatal Conjunctivitis
  • Allergic Conjunctivitis
  • Bacterial Conjunctivitis
  • Non-Infectious Uveitis

Pulmonary

  • Allergic Rhinitis
  • Asthma
  • Chronic idiopathic urticaria
  • Bronchospasms
  • Bronchopulmonary dysplasia

Other

  • Symptoms associated with common cold and influenza
  • Smoking Cessation
  • Juvenile Rheumatoid Arthritis
  • Detrusor hyperreflexia

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FDA/Center for Drug Evaluation and Research
Last Updated: November 10, 2004
Originator: OND/OPDDPI 
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