|
Approval Date
| Drug
|
Indications
| Types of Studies
|
Age/Number of Patients Studied
|
Approved Actions in the Pediatric Population |
|
9/17/1999 |
Accolate Tablets (zafirlukast) AstraZeneca |
Prophylaxis and chronic treatment of asthma |
4-week, multicenter, randomized, double-blind, placebo controlled,
dose ranging, safety, efficacy and multiple-dose PK study |
Age 5-11 yr.,
311 patients
|
-
Approved down to 7 years of age
- Efficacy extrapolated from demonstrated efficacy in patients 15
years and older
|
|
4/4/2000 |
*Humalog Injection (insulin lispro) Lilly |
Type 1 diabetes |
9-month, cross-over, open-label, safety and efficacy study
|
Age 3-12 yr.,
60 patients
|
-
Approved for use in the pediatric population
- Instructions on use of the diluted product in the pediatric
population
|
|
8-month, cross-over, open-label, safety and efficacy study
|
Age 9-18 yr,.
463 patients
|
|
6/16/2000 |
AmBisome Injection (amphotericin B) Fujisawa |
Cryptococcal meningitis in HIV infected patients |
Escalating dose, PK study |
Age 1-16 yr.,
47 patients |
- New indication approved down to 1 year of age
- Established a dose of 6mg/kg/day
|
|
7/14/2000 |
*ChloraPrep OneStep OTC (chlorhexidine/ isopropyl alcohol)
Medi-Flex
Hospital Products |
Skin preparation prior to surgery |
Extrapolated information from adult data |
|
- New indication approved down to 2 months
- Warning: do not use in less than 2 months of age
|
|
11/17/2000 |
Tamiflu Capsule (oseltamivir) Roche |
Prophylaxis of influenza A and B |
7-day, multicenter, household randomized, double-blind, placebo-controlled safety and efficacy study |
Age13-18 yr.,
405 patients
|
-
Approved for prophylactic use down to 13 years of age
|
|
12/8/2000 |
Protopic Ointment (tacrolimus) Fujisawa |
Atopic dermatitis |
Multiple-dose, PK study |
Age 2-15 yr.,
20 patients |
- Approved down to 2 years of age
- Lower dose of 0.03% twice daily recommended for pediatric patients
|
|
12-week, multicenter randomized, double- blind, placebo-
controlled safety and efficacy study and 1-year open-label safety
study |
Age 2-15 yr.,
606 patients
|
|
12/20/2000 |
CellCept IV, Suspension, Capsules (mycophenylate) Hoffman-
LaRoche |
Prophylaxis of organ rejection in renal transplant patients |
12-month, multicenter, open-label, PK and safety study in combination with
cyclosporine and corticosteroids |
Age 3 mo.-18 yr.,
100 patients |
- Approved for use down to 3 months of age as a combination regimen
|
|
6/25/2001 |
Valtrex Caplets (valacyclovir) GSK |
Treatment of cold sores |
Randomized, double- blind, placebo- controlled, safety and efficacy study |
Age12-18 yr.,
84 patients |
-
New indication approved for use down to 12 years of age
|
|
1/30/2002 |
Xopenex Inhalation Solution (levalbuterol) Sepracor |
Treatment and prevention of bronchspasm |
Population PK study
|
Age 6-11 yr.,
76 patients
|
- Approved down to 6 years of age
- Recommended dose is 0.31mg TID for patients 6-11 years
|
|
3-week, multicenter, double-blind, active control, safety and
efficacy study |
Age 6-11 yr., 338 patients
|
|
6/5/2002 |
Ritalin LA Capsules (methylphenidate) Novartis |
Attention Deficit Hyperactivity Disorder |
4-week, double-blind, placebo-controlled, safety and efficacy study; single-dose PK
performed in a subset |
Age 6-12 yr.,
195 patients
|
- Approved for use in 6-12 year olds
- Once a day dose in the morning
|
|
12/4/2002 |
Mupirocin Ointment 2% Clay-Parks Labs |
Treatment of impetigo |
Multicenter, double-blind, active control, safety and efficacy study |
Age 2-15 yr.,
413 patients |
-
Approved for use down to 2 months of age
|
|
12/31/2002 |
Singulair Granules, Tablets, Chewable tablets (montelukast) Merck |
Seasonal allergic rhinitis |
2-week, multicenter, double-blind, active control, safety study |
Age 2-14 yr.,
413 patients |
- New indication approved for use down to 2 years of age
- Efficacy extrapolated from demonstrated efficacy in patients 15
years and older
|
