TABLE 1

Drugs Whose Labeling Has New Pediatric Pharmacokinetic and/or Dosing Information11

Drug (Brand Name; Date Labeled)Therapeutic ClassPediatric Indication in Labeling
Midazolam (Versed syrup; October 15, 1998)Sedative hypnotic agentSedation, anxiolysis, amnesia
Atovaquone/proguanil (Malarone; July 14, 2000)Antimalarial agentProphylaxis and treatment of malaria
Etodolac (Lodine XL; August 11, 2000)Nonsteroidal antiinflammatory drugRelief of symptoms of juvenile rheumatoid arthritis
Fluvoxamine (Luvox; September 28, 2000)Selective serotonin reuptake inhibitorObsessive-compulsive disorder
Gabapentin (Neurontin; October 12, 2000)Second-generation anticonvulsantAdjunctive therapy in treatment of partial seizures
Cromolyn (Nasalcrom; March 27, 2001)Mast cell stabilizerAllergic rhinitis
Lamivudine (Epivir; August 16, 2001)Antiviral agentHepatitis B virus
Sotalol (Betapace; October 3, 2001)Antiarrhythmic agentSafety and effectiveness of Betapace AF in children have not been established
Stavudine (Zerit; March 29, 2002)Antiviral agentHIV
Famotidine (Pepcid; June 6, 2002)Histamine H2 receptor antagonistGastroesophageal reflux
Lamivudine (Epivir; October 8, 2002)Antiviral agentHIV
Fluoxetine (Prozac; January 3, 2003)Selective serotonin reuptake inhibitorMajor depressive disorder and obsessive-compulsive disorder
Benazepril (Lotensin; March 2, 2004)Angiotensin-converting enzyme inhibitorHypertension
Leflunomide (Arava; March 5, 2004)Immunomodulatory agentNone; safety and efficacy in pediatric patients with polyarticular juvenile rheumatoid arthritis have not been fully evaluated
Remifentanil (Ultiva; March 9, 2004)Analgesic/anesthetic agentMaintenance of anesthesia
Nelfinavir (Viracept; March 19, 2004)Antiviral agentHIV-1
Methylphenidate (Concerta; October 21, 2004)PsychostimulantADHD
Ondansetron (Zofran; March 25, 2005)Antiemetic agentPrevention of chemotherapy-induced and postoperative induced nausea and vomiting
Linezolid (Zyvox; December 19, 2002, and May 12, 2005)Antibacterial agentInfection
Levetiracetam (Keppra; June 21, 2005)Antiepileptic drugAdjunctive therapy in treatment of partial onset seizures
Amphetamine mixed salts (Adderall XR; July 21, 2005)Central nervous system stimulantADHD
Oxcarbazepine (Trileptal; October 28, 2005)Antiepileptic drugUse as monotherapy in treatment of partial seizures in children ≥4 y of age and as adjunctive therapy in children ≥2 y of age with epilepsy
Irbesartan (Avapro)Angiotensin II receptor antagonistNone; at doses of up to 4.5 mg/kg once daily, irbesartan did not seem to lower blood pressure effectively in pediatric patients 6–16 y of age