 |
 |
 |
|
 |
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA
N= 56 (BPCA = 27; PREA = 29)
Approval Date |
Product |
Indication(s) |
Study # |
Study Type |
Study Design |
No Patients |
No Centers |
No Countries |
BPCA (B) PREA (P) |
|---|---|---|---|---|---|---|---|---|---|
10/29/2007 & 2/27/2008 |
Abilify (aripiprazole) Tablets 5/10/15/20/30 mg |
Bipolar Disorder 11- 17 years; |
1 |
Efficacy / Safety |
Blind / Placebo / Parallel Group |
296 |
59 |
1 |
B |
Bipolar Disorder 11- 17 years; Schizophrenia 13-17 years of age |
2 |
Pharmacokinetic |
Open-label / Population Pharmacokinetic |
21 |
1 |
1 |
|||
Schizophrenia 13-17 years of age |
3 |
Efficacy / Safety |
Blind / Placebo / Parallel Group |
302 |
101 |
13 |
|||
Bipolar Disorder 11- 17 years; Schizophrenia 13-17 years of age |
4 |
Safety / Tolerability |
Open-label |
325 |
152 |
13 |
|||
10/21/2008 |
Acanya (clindamycin / benzoyl peroxide) Gel |
Topical treatment of acne vulgaris in patients 12 years or older |
1 |
Other |
Blind / Placebo |
705 |
12 |
1 |
P |
2 |
Efficacy / Safety |
Blind / Placebo / Parallel Group |
850 |
35 |
3 |
|
|||
3 |
Efficacy / Safety |
Blind / Placebo / Parallel Group |
905 |
33 |
1 |
||||
4 |
Efficacy / Safety |
Blind / Placebo / Parallel Group |
285 |
14 |
1 |
||||
6/30/2008 |
Aciphex (rabeprazole) Delayed Release Tablets 20 mg |
GERD in adolescent patients 12 years of age and older |
1 |
Efficacy / Safety |
Open-label |
111 |
25 |
1 |
B |
2 |
Pharmacokinetic |
Open-label / Traditional Pharmacokinetic |
24 |
7 |
1 |
||||
1/10/2008 |
Alvesco (ciclesonide) Inhalation Aerosol, 80 mcg & 160 mcg |
Treatment of asthma in patients 12 years of age and older |
1 |
Efficacy / Safety |
Blind / Placebo / Parallel Group / Dose Response |
514 |
67 |
2 |
P |
2 |
Efficacy / Safety / Dose Response |
Blind / Placebo / Parallel Group |
517 |
64 |
2 |
||||
3 |
Safety |
Open Label |
193 |
26 |
1 |
||||
4 |
Safety |
Open Label |
190 |
26 |
1 |
||||
5 |
Safety |
Open Label |
232 |
29 |
1 |
||||
6 |
Safety / Pharmacodynamic |
Placebo |
24 |
1 |
1 |
||||
7 |
Efficacy / Safety / Tolerability |
Blind |
728 |
51 |
1 |
||||
12/27/2007 |
AndroGel (testosterone) Gel 1% |
Delayed puberty due to hypogonadism or constitutional delay of growth and puberty |
1 |
Safety / Pharmacokinetic / Dose Response |
Open-label |
17 |
6 |
1 |
B |
2 |
Efficacy / Safety |
Open-label |
86 |
18 |
1 |
||||
10/24/2008 |
Apidra (insulin glulisine [rDNA origin] injection) |
Improve glycemic control in adults and children with diabetes mellitus |
1 |
Efficacy / Safety |
Open Label / Parallel Group |
572 |
65 |
16 |
P |
2 |
Safety / Pharmacokinetc / Pharmacodynamic |
Blind / Traditional Pharmacokinetic / Crossover |
20 |
1 |
1 |
||||
6/23/2008 |
Aptivus (tipranavir) Capsule 250 mg, Solution 100 mg / mL |
In combination with ritonavir in HIV-1 infected children in 2 – 18 years of age |
1 |
Safety / Pharmacokinetic / Tolerability |
Open Label / Traditional Pharmacokinetic |
110 |
24 |
8 |
B |
5/5/2008 |
Argatroban (argatroban) Injection 100 mg / mL |
Heparin-Induced Thrombocytopenia (HIT) or HIT with Thrombosis in children 0-16 years of age |
1 |
Efficacy / Safety / Pharmacokinetic / Pharmacodynamic |
Open Label / Traditional Pharmacokinetic |
11 |
12 |
1 |
B |
12/5/2008 |
Arimidex (anastrozole) Tablet 1 mg |
Gynecomastia in boys in 11-18 years of age and McCune-Albright Syndrome in girls less than or equal to 10 years of age |
1 |
Efficacy / Safety |
Blind / Placebo / Parallel Group |
80 |
24 |
1 |
B |
2 |
Efficacy / Safety |
Open-label |
28 |
14 |
7 |
||||
3 |
Pharmacokinetic / Pharmacodynamic |
Open-label / Traditional Pharmacokinetic |
38 |
2 |
1 |
||||
4 |
Pharmacokinetic |
Open-label / Population Pharmacokinetic |
64 |
2 |
2 |
||||
3/19/2008 |
Artiss (fibrin sealant (Human)) |
To adhere autologous skin grafts to surgically prepared wound beds resulting from burns in adult and pediatric populations |
2 Studies |
Efficacy / Safety |
Active Control / Blind |
138 |
13 |
1 |
P |
2/1/2008 |
Asmanex (mometasone furoate inhalation powder) Twisthaler 110mcg |
Maintenance treatment of asthma as prophylactic therapy in children 4 years of age and older |
1 |
Efficacy / Safety |
Blind / Placebo / Parallel Group |
296 |
39 |
6 |
P |
2 |
Efficacy / Safety |
Blind / Placebo / Parallel Group |
349 |
25 |
1 |
||||
3 |
Efficacy / Safety |
Blind / Placebo / Parallel Group |
290 |
20 |
6 |
||||
4 |
Safety |
Blind / Placebo / Parallel Group |
50 |
1 |
1 |
||||
5 |
Safety |
Blind / Placebo / Parallel Group |
187 |
29 |
1 |
||||
6 |
Safety |
Open Label / Active Control |
233 |
21 |
1 |
||||
7 |
Safety |
Blind / Placebo / Crossover |
23 |
1 |
1 |
||||
8 |
Safety |
Blind / Placebo / Active Control / Crossover |
51 |
1 |
1 |
||||
7/29/2008 |
Cancidas (caspofungin) lyophilized powder for infusion 50 and 70 mg / m2 |
Aspergillosis and candida infections in 3 months – 17 years of age |
1 |
Safety / Pharmacokinetic / Dose Response |
Open Label / Traditional Pharmacokinetic |
39 |
8 |
1 |
B |
2 |
Safety / Pharmacokinetic / Tolerability |
Open Label / Traditional Pharmacokinetic |
9 |
5 |
1 |
||||
3 |
Safety / Pharmacokinetic / Tolerability |
Open Label / Traditional Pharmacokinetic |
18 |
8 |
5 |
||||
4 |
Efficacy / Safety / Tolerability |
Open Label |
49 |
12 |
5 |
||||
5 |
Efficacy / Safety / Tolerability |
Blind / Placebo / Parallel Group / |
82 |
17 |
4 |
||||
4/30/2008 |
Cardiolite (technetium tc99m sestamibi) Kit |
Myocardial perfusion imaging in 4-17 years of age |
1 |
Safety / Pharmacokinetic |
Open Label / Traditional Pharmacokinetic |
78 |
10 |
3 |
B |
2 |
Efficacy / Safety |
Blind / Placebo |
445 |
51 |
8 |
||||
3 |
Efficacy / Safety |
Other |
86 |
19 |
5 |
||||
12/19/2008 |
Casodex (bicalutamide) Tablets 50 mg |
Precocious puberty in boys with testotoxicosis. |
1 |
Efficacy |
Open-label / Active Comparator / Parallel Group |
14 |
10 |
3 |
B |
3/12/2008 |
Daptacel (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP)) |
Active immunization against diphtheria, tetanus & pertussis as a five dose series in children 6 weeks through 6 years of age (prior to 7th birthday) |
1 |
Safety / Immunogenicity |
Open Label |
649 |
22 |
1 |
P |
3/24/2008 |
Depakote ER (valproate) Tablets 250, 500 mg and Sprinkles 125 mg Capsules |
Migraine prophylaxis in 12 -17 years of age; |
1 |
Efficacy / Safety |
Blind / Placebo / Parallel Group / Dose Response |
304 |
38 |
1 |
B |
Adolescent Bipolar Disorder in association with bipolar disorder in 10-17 years of age; |
2 |
Efficacy |
Blind / Placebo / Parallel Group |
144 |
24 |
1 |
|||
Partial seizures in 3-10 years of age |
3 |
Safety |
Open-label |
169 |
29 |
2 |
|||
12/12/2007 |
Derma-Smoothe (fluocinolone) Topical Oil, 0.01% Body Oil |
Treatment of atopic dermatitis in pediatric patients 3 months and older for up to 4 weeks |
1 |
Safety |
Open Label |
32 |
2 |
1 |
P |
5/8/2008 |
Desmopressin acetate (desmopressin acetate) Tablets, 0.1 mg and 0.2 mg |
Determine the capacity of the kidney to concentrate urine in pediatric patients (Renal Concentration Capacity Test or RCCT) and management of primary nocturnal enuresis (PNE) |
1 |
Efficacy / Safety |
Blind / Placebo |
145 |
6 |
1 |
P |
2 |
Efficacy / Safety |
Open Label |
58 |
2 |
1 |
||||
3 |
Efficacy |
Blind / Parallel Group |
31 |
14 |
1 |
||||
4 |
Efficacy |
Blind / Crossover |
23 |
1 |
1 |
||||
5 |
Efficacy |
Open Label |
30 |
1 |
1 |
||||
6 |
Efficacy |
Open Label |
38 |
11 |
1 |
||||
7 |
Efficacy |
Open Label |
249 |
9 |
1 |
||||
11/29/2007 |
Diovan (valsartan) 40, 80, 160, and 320 mg Tablets. |
Hypertension in 1-16 years of age |
1 |
Pharmacokinetic |
Open Label / Traditional Pharmacokinetic |
26 |
6 |
2 |
B |
2 |
Safety |
Blind / Placebo / Parallel Group / Dose Response |
261 |
55 |
9 |
||||
3 |
Safety |
Blind / Placebo / Parallel Group / Dose Response |
90 |
36 |
7 |
||||
12/11/2008 |
Epiduo (adapalene and benzoyl peroxide) Gel 0.1% / 2.5% |
Topical treatment of acne vulgaris in patients 12 years of age and older |
1 |
Efficacy / Safety |
Blind / Active Control / Parallel Group |
1091 |
60 |
3 |
P |
2 |
Efficacy / Safety |
Blind / Active Control / Parallel Group |
401 |
36 |
1 |
||||
3 |
Efficacy / Safety |
Open Label |
299 |
29 |
1 |
||||
4 |
Efficacy / Safety |
Open Label / Parallel Group |
150* |
3 |
1 |
||||
5 |
Efficacy / Safety / Tolerability |
Blind / Placebo / Parallel Group |
173 |
8 |
1 |
||||
1/16/2008 |
Evicel (fibrin sealant (Human)) |
Adjunct to hemostasis for use in patients undergoing surgery, when control of bleeding by standard surgical techniques is ineffective or impractical |
3 Studies |
Efficacy / Safety |
Active Control |
135 |
16 |
1 |
P |
12/19/2007 |
Hepsera (adefovir) Tablet 10 mg |
Chronic hepatitis B in 2-18 years of age |
1 |
Efficacy / Safety |
Blind / Placebo / Parallel Group |
173 |
26 |
6 |
B |
2 |
Safety / Pharmacokinetic |
Open Label / Traditional Pharmacokinetic |
45 |
10 |
1 |
||||
2/21/2008 |
Humira (adalimumab) |
Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 4 years of age and older |
1 |
Efficacy / Safety |
Open Label / Blind |
171 |
31 |
8 |
P |
1/31/2008 |
Inspra (eplerenone) Tablets 25, 50, 100 mg |
Treatment of Hypertension in patients 6 – 16 years of age |
1 |
Efficacy / Safety |
Blind / Placebo / Parallel Group / Dose Response |
304 |
43 |
5 |
B |
2 |
Safety / Pharmacokinetic |
Open Label / Traditional Pharmacokinetic |
149 |
20 |
3 |
||||
3 |
Pharmacokinetic |
Open Label / Traditional Pharmacokinetic |
18 |
1 |
1 |
||||
6/20/2008 |
Kaletra (lopinavir / ritonavir) Tablets 25 mg, 50 mg, 100 mg, 200 mg, Capsules 33.3 mg and 133.3 mg, Solution 20 mg / mL, 80 mg / dL |
Use in combination with other antiretroviral agents for HIV-1 infection |
1 |
Safety / Pharmacokinetic / Tolerability |
Open Label / Traditional Pharmacokinetic |
31 |
17 |
2 |
B |
2 |
Efficacy / Safety / Pharmacokinetic / Tolerability |
Open Label / Traditional Pharmacokinetic |
26 |
15 |
1 |
||||
3 |
Efficacy / Safety / Pharmacokinetic / Tolerability |
Open Label / Traditional Pharmacokinetic |
100 |
10 |
6 |
||||
6/24/2008 |
Kinrix (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus) Vaccine |
Active immunization against diphtheria, tetanus, pertussis, & poliomyelitis as the fifth dose in the diphtheria, tetanus, & acellular pertussis (DTaP) series & the fourth dose in the inactivated poliovirus vaccine (IPV) in children 4 - 6 years of age whose previous DTaP vaccine doses have been INFANRIX and / or PEDIARIX for the first three doses & INFANRIX for the fourth dose |
3 Studies |
Safety / Immunogenicity |
Open Label / Active Control |
3537 |
41 |
2 |
P |
10/10/2008 |
Kogenate FS (Antihemophilic Factor (Recombinant)) |
Routine prophylaxis to reduce the frequency of bleeding episodes and the risk of joint damage in children with hemophilia A with no pre-existing joint damage |
2 Studies |
Efficacy / Safety |
Open Label / Blind / Parallel Group |
65 |
14 |
1 |
P |
9/28/2007 |
Lamisil (terbinafine) Oral Granules, 125, 187.5 mg. |
Tinea capitis in 4-12 years of age |
1 |
Pharmacokinetic |
Open label / Traditional |
16 |
1 |
1 |
B |
|
|
2 |
Efficacy / Safety |
Blind / Active Comparator / Parallel Group |
747 |
74 |
7 |
|||
|
|
3 |
Efficacy / Safety |
Blind / Active Comparator / Parallel Group |
802 |
72 |
9 |
|||
3/31/2008 |
Lancôme UV Expert 40, La Roche-Posay Anthelios 40, Vichy Capital Soleil 40 (helioblock SX) Anthelios 40 (2% avobenzone, 3% ecamsule, 10% octocrylene and 5% titanium dioxide cream) Sunscreen Cream |
Helps prevent sunburn; higher SPF gives more sunburn protection; helps provide protection from UVA rays |
1 |
Safety |
Open Label |
135 |
4 |
1 |
P |
2 |
Safety |
Open Label |
363 |
14 |
4 |
||||
3/19/2009 |
Lexapro (escitalopram oxalate) Tablets 5 mg, 10 mg, and 20 mg and Oral solution 5 mg / mL |
Acute and maintenance treatment of major depressive disorder adolescents 12 to 17 years of age |
1 |
Efficacy / Safety |
Blind / Placebo / Parallel Group |
312 |
40 |
1 |
B |
2 |
Efficacy / Safety |
Blind / Placebo / Open Label / Parallel Group |
202 |
35 |
1 |
||||
3 |
Efficacy / Safety |
Blind / Placebo / Parallel Group |
264 |
25 |
1 |
||||
4 |
Efficacy / Safety |
Blind / Placebo / Parallel Group |
174 |
21 |
1 |
||||
5 |
Efficacy / Safety |
Blind / Placebo / Parallel Group |
233 |
31 |
7 |
||||
1/23/2008 |
Moxatag (amoxicillin) Extended-release Tablet, 775 mg |
Use for tonsillitis and / or pharyngitis secondary to Streptococcus pyogenes patients 12 years of age and older |
1 |
Efficacy / Safety |
Blind / Placebo / Parallel Group |
142 |
64 |
1 |
P |
2 |
Efficacy / Safety |
Blind / Placebo / Parallel Group |
139 |
50 |
2 |
||||
9/19/2008 |
Nasacort AQ (triamcinolone acetonide) Nasal Spray |
Treatment of the nasal symptoms of seasonal and perennial allergic rhinitis in adults and children 2 years of age and older |
1 |
Safety / PK |
Open Label / Traditional Pharmacokinetic |
15 |
6 |
1 |
P |
2 |
Safety |
Placebo / Blind / Crossover |
59 |
1 |
1 |
||||
3 |
Efficacy / Safety |
Blind / Placebo / Parallel Group |
474 |
64 |
1 |
||||
2/27/2008 |
Nexium (esomeprazole) Delayed-Release Granules for Oral Suspension 10 mg |
Short-term treatment of symptomatic GERD and erosive esophagitis in 1-11 year olds |
1 |
Efficacy / Safety |
Blind / Placebo / Parallel Group |
109 |
24 |
1 |
B |
2 |
Pharmacokinetic |
Open Label / Traditional Pharmacokinetic |
31 |
1 |
1 |
||||
3/14/2008 |
NovoLog (insulin aspart [rDNA origin] injection) |
Insulin analog indicated to improve glycemic control |
1 |
Efficacy / Safety |
Open Label / Active Control / Parallel Group |
298 |
45 |
1 |
P |
2 |
Efficacy / Safety |
Open Label / Active Control / Parallel Group |
61 |
5 |
1 |
||||
11/21/2007 |
Omnaris (ciclesonide) Nasal Spray |
Treatment of seasonal allergic rhinitis (SAR) in patients 6 through less than 12 years of age |
1 |
Safety / Tolerability |
Blind / Placebo / Parallel Group |
125 |
3 |
1 |
P |
2 |
Efficacy / Safety |
Blind / Placebo / Parallel Group |
618 |
69 |
1 |
||||
5/9/2008 |
OraVerse (phentolamine mesylate) Injection 0.4 mg (0.235 mg / mL) |
Reversal of soft-tissue anesthesia, i.e., anesthesia of the lip and tongue, and the associated functional deficits resulting from an intraoral submucosal injection of a local anesthetic containing a vasoconstrictor |
1 |
Efficacy / Safety / Pharmacodynamic |
Blind / Placebo |
31 |
18 |
1 |
P |
2 |
Efficacy / Safety / Pharmacodynamic |
Blind / Placebo |
24 |
16 |
1 |
||||
3 |
Efficacy / Safety |
Blind / Placebo |
152 |
11 |
1 |
||||
4 |
Efficacy / Safety |
Blind / Placebo |
26 |
7 |
1 |
||||
5 |
Safety / PK |
Open Label / Traditional Pharmacokinetic |
19 |
3 |
1 |
||||
|
|
|
|
|
|
|
||||
4/7/2008 |
Orencia (abatacept) |
Reducing signs and symptoms in pediatric patients 6 years of age and older with moderately to severely active polyarticular juvenile idiopathic arthritis |
1 |
Efficacy / Safety |
Open Label / Blind |
214 |
45 |
11 |
P |
4/15/2008 |
Patanase (olopatadine hydrochloride) Nasal Spray |
Relief of symptoms of seasonal allergic rhinitis (SAR) in patients 12 years of age and older |
1 |
Efficacy / Safety |
Blind / Placebo / Parallel Group |
56 |
33 |
1 |
P |
2 |
Efficacy / Safety |
Blind / Placebo / Parallel Group |
50 |
7 |
1 |
||||
3 |
Safety |
Placebo / Parallel Group |
924* |
43 |
1 |
||||
4 |
Efficacy / Safety |
Blind / Placebo / Parallel Group |
192* |
7 |
1 |
||||
5 |
Efficacy / Safety |
Blind / Active Control / Placebo / Parallel Group |
166* |
13 |
1 |
||||
6 |
Efficacy / Safety |
Blind / Active Control / Placebo |
397* |
17 |
1 |
||||
7 |
Efficacy |
Blind / Active Control / Placebo / Parallel Group |
90* |
1 |
1 |
||||
6/20/2008 |
Pentacel (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate)) Vaccine |
Active immunization against diphtheria, tetanus, pertussis, poliomyelitis and invasive disease due to Haemophilus influenzae type b |
14 Studies |
Safety / Immunogenicity |
Open Label / Active Control |
10356 |
153 |
4 |
P |
10/28/2008 |
Prevacid (lansoprazole) Delayed-Release Capsules, Delayed-Release Oral Suspension, and SoluTab Delayed-Release Orally Disintegrating Tablets, 15, 30 mg. in children 0-11 months |
GERD in neonates 28 days to 11 months, and 1 -17 years of age |
1 |
Efficacy / Safety / Pharmacokinetic |
Blind / Placebo / Parallel Group Traditional Pharmacokinetic / Pharmacodynamic |
162 |
8 |
2 |
B |
2 |
Efficacy / Safety / Pharmacokinetic |
Open label / Traditional Pharmacokinetic / Pharmacodynamic |
66 |
11 |
1 |
||||
3 |
Efficacy / Safety / Pharmacokinetic |
Open label / Traditional Pharmacokinetic / Pharmacodynamic |
63 |
10 |
1 |
||||
4 |
Efficacy / Safety / Pharmacokinetic |
Open label / Traditional Pharmacokinetic / Pharmacodynamic |
87 |
20 |
1 |
||||
12/18/2008 |
Prezista (darunavir) Tablet 75 mg, 300mg |
Treatment of HIV infection in pediatric patients 6 years and older when co-administered with ritonavir (Prezista / rtv), and with other antiretroviral agents |
1 |
Safety / Pharmacokinetic |
Open Label / Traditional Pharmacokinetic |
80 |
12 |
9 |
B |
3/20/2008 |
Prilosec (omeprazole) for Delayed-Release Oral Suspension |
Maintenance healing of erosive esophagitis |
1 |
Pharmacokinetic |
Open Label / Traditional Pharmacokinetic |
25 |
11 |
3 |
B |
2 |
Efficacy |
Other |
43 |
8 |
3 |
||||
3/25/2008 |
Reyataz (atazanavir) |
HIV in 6 years and older |
1 |
Safety / Pharmacokinetic |
Open Label / Traditional Pharmacokinetic |
182 |
3 |
2 |
B |
9/3/2008 |
Valtrex (valacyclovir) Caplets 500 mg and 1000 mg |
Herpes Virus Infection in 1 – 18 years of age |
1 |
Safety / Pharmacokinetic / Tolerability |
Open Label / Traditional Pharmacokinetic |
57 |
15 |
4 |
B |
2 |
Safety / Pharmacokinetic / Tolerability |
Open Label / Traditional Pharmacokinetic |
28 |
9 |
4 |
||||
3 |
Safety / Pharmacokinetic / Tolerability |
Open Label / Traditional Pharmacokinetic |
27 |
7 |
4 |
||||
3/26/2008 |
Ventolin HFA (albuterol) Oral Inhalation Aerosol |
Treatment and prevention of bronchospasm in children from birth to <4 years of age with obstructive airway disease |
1 |
Efficacy / Safety |
Blind / Placebo / Parallel Group |
77 |
37 |
1 |
B |
2 |
Efficacy / Safety |
Blind / Placebo / Parallel Group |
86 |
33 |
1 |
||||
3 |
Efficacy / Safety |
Blind / Parallel Group |
87 |
16 |
1 |
||||
6/24/2008 |
Viramune (nevirapine) Tablets 200 mg & Oral Suspension 10 mg / ml |
Use in combination with other antiretroviral agents for the treatment of HIV-1 infection |
1 |
Safety / Tolerability / Pharmacokinetic |
Open Label / Traditional Pharmacokinetic |
123 |
4 |
1 |
P |
12/28/2007 |
Voluven (6% Hydroxyethyl Starch 130 / 0.4 in 0.9% Sodium Chloride) Injection |
Treatment and prophylaxis of hypovolemia |
1 |
Efficacy / Safety |
Blind |
100 |
6 |
1 |
P |
8/28/2008 |
Zemuron (rocuronium) Injection 10 mg / mL |
Adjunct to general anesthesia |
1 |
Efficacy / Safety |
Blinded / Dose Response |
207 |
19 |
2 |
B |
2 |
Safety / Pharmacokinetic / Pharmacodynamic |
Open Label / Dose Response |
149 |
23 |
3 |
||||
6/5/2008 and 6/13/2008 |
Zetia (ezetimibe) Tablets 10 mg and Vytorin (ezetimibe / simvastatin ) Tablets 10 / 10 mg, 10 / 20 mg, 10 / 40 mg |
Heterozygous Familial Hypercholesterolemia in 10 – 17 years of age |
1 |
Efficacy / Safety |
Blind / Parallel Group / Active Control |
248 |
47 |
2 |
B |
12/19/2008 |
Ziagen (abacavir) |
Treatment of HIV-1 infection in pediatric patients weighing >14 kg |
1 |
Pharmacokinetic |
Open Label / Traditional Pharmacokinetic |
22 |
11 |
1 |
B |
2 |
Pharmacokinetic |
Open Label / Traditional Pharmacokinetic |
46 |
1 |
1 |
||||
3 |
Safety / Pharmacokinetic |
Open Label / Traditional Pharmacokinetic |
14 |
1 |
1 |
||||
4 |
Efficacy / Safety |
Blind / Parallel Group / Active Control |
205 |
29 |
2 |
|
|||
10/7/2008 |
Zmax (azithromycin extended release) for oral suspension |
Treatment of mild to moderate infections caused by susceptible isolates of the designated microorganisms: Community-acquired pneumonia in pediatric patients six months of age or older due to C. pneumoniae, H. influenzae, M. pneumoniae or S. pneumoniae, in patients appropriate for oral therapy |
1 |
Efficacy / Safety |
Blind / Placebo / Active Control |
923 |
60 |
13 |
P |
2 |
Efficacy / Safety |
Blind / Placebo / Active Control |
673 |
32 |
5 |
||||
3 |
Efficacy / Safety / Tolerability / Pharmacokinetic |
Open Label / Traditional Pharmacokinetic |
44 |
2 |
1 |
||||
3/20/2008 |
Zometa (zoledronic acid) Vial for Infusion 5 mg |
Severe osteogenesis imperfecta in 1-17 years of age |
1 |
Pharmacokinetic |
Open Label / Traditional Pharmacokinetic |
11 |
5 |
3 |
B |
2 |
Efficacy / Safety |
Blind / Parallel Group / Active Control |
150 |
20 |
9 |
||||
8/14/2008 |
Zyprexa (olanzapine) Tablets 2.5, 5, 7.5, 10, 15 20 mg |
schizophrenia in 13-17 years of age; |
1 |
Efficacy / Safety |
Blind / Parallel Group / Placebo |
107 |
20 |
2 |
B |
schizophrenia and bipolar disorder in 13-17 years of age; |
2 |
Pharmacokinetic |
Open label / Population Pharmacokinetic |
107 |
22 |
2 |
|||
schizophrenia and bipolar disorder in 13-17 years of age; |
3 |
Safety / Pharmacokinetic |
Open label |
96 |
10 |
1 |
|||
bipolar disorder in 13-17 years of age |
4 |
Pharmacokinetic |
Open Label / Traditional Pharmacokinetic |
8 |
1 |
1 |
|||
bipolar disorder in 13-17 years of age |
5 |
Efficacy / Safety |
Blind / Parallel Group / Placebo |
217 |
25 |
1 |
|||
bipolar disorder in 5-14 years of age |
6 |
Efficacy / Safety |
Open label |
23 |
1 |
1 |
The table above contains pediatric assessments (or studies) made under sections 505B and 505A of the Federal Food, Drug, and Cosmetic Act (the Act), as amended by the FDA Amendments Act of 2007 (FDAAA). In accordance with sections 505B(f)(6) and 505A(f)(6) of the Act, as amended by FDAAA, the list identifies those products approved on or after September 27, 2007, that fell within the scope of the Pediatric Research Equity Act (PREA) and/or the Best Pharmaceuticals for Children Act, and contained new pediatric information.
This list specifically highlights the number of assessments (or studies) conducted under the sections referenced above, the specific drugs and their uses, and the types of assessments conducted, including trial design, number of pediatric patients studied, and the number of centers and countries involved.
* = Patient number includes adults
Study Types
1. Efficacy: Efficacy studies are done to provide evidence of a drug’s ability to diagnosis, cure, mitigation, treatment, or prevention of a disease. Efficacy information may be found in the drug labeling Indications & Usage, Use in Specific Populations, and Clinical Studies sections.
2. Safety: Safety studies provide evidence of a drug’s medical risk to humans. Safety is usually determined by collecting information on laboratory and/or other tests (for example, electrocardiogram and vision), vital signs, and drug side effects. Safety information may be found in the drug labeling Warnings & Precautions, Adverse Reactions, and Use in Specific Populations sections.
3. Pharmacokinetic (PK): Pharmacokinetic studies provide information on what the body does to a drug. More specifically, it covers how a drug is absorbed, distributed, metabolized and eliminated by the body. Pediatric PK studies are generally performed in patients, and focus on the measurement of drug in blood, urine, or in other body fluids or tissues.
Pharmacokinetic studies are often conducted during initial drug development in order to:
Pharmacokinetic information may be found in the drug labeling Clinical Pharmacology section.
4. Pharmacodynamic (PD): Pharmacodynamic studies provide information on what a drug does to the body. PD examines how a drug works in the body and the amount of drug needed to provide an effect. Pharmacodynamic information may be found in the drug labeling Clinical Pharmacology section.
5. Pharmacokinetic/Pharmacodynamic (PK/PD): A drug’s pharmacokinetic effect is usually expressed along with its pharmacodynamic effect. (The relationship between what a drug does to the body and what the body does to a drug.) PK/PD information may be found in the drug labeling Clinical Pharmacology section.
6. Tolerability: Tolerability of a drug is the degree to which drug-related side effects can be accepted by a patient. Tolerability is usually associated with the safety of a drug. Tolerability information may be found in the drug labeling Warnings & Precautions and Adverse Reactions sections.
7. Nonclinical: Nonclinical studies are usually conducted in a laboratory setting, and may involve in vitro (test tube) and in vivo (animal) studies. There is no testing of human subjects. Nonclinical information may be found in the drug labeling Nonclinical Toxicology section.
8. Neonatal: Neonatal studies involve pediatric patients 0 to 1 month of age. Neonatal study information may be found in the drug labeling Use in Specific Populations/Pediatric Use section.
9. Actual Use: Actual Use studies provide information about whether subjects can self-diagnose a medical condition, use a drug product safely, and follow labeling instructions without the assistance of a healthcare professional (for example, doctor, nurse, or pharmacist). These studies are conducted for products intended to be marketed over-the counter (OTC). Actual Use study information may be found in the drug labeling Clinical Studies section.
10. Oncology: Oncology studies focus on the diagnosis, cure, mitigation, treatment, or prevention of cancer in patients. Oncology study information may be found in the drug labeling Clinical Studies section.
11. Immunogenicity: These studies test efficacy by measuring the antibody response of the patient to the vaccine.
12. Other: Any study that does not involve the types described above.
Study Designs
1. Traditional Pharmacokinetic (PK): Traditional PK studies involve administration of the study drug to a subject followed by intensive sampling of blood, urine or other body fluid, which is used to measure the drug in those fluids. These studies usually enroll small groups of patients (less than 20).
2. Population Pharmacokinetic: Sometimes called "Pop PK studies", they involve administration of the study drug to a larger group of patients, followed by less frequent sampling of body fluids, Computer models are then used to identify certain demographic characteristics, such as weight or age, that influence how the drug passes through the body, without having to conduct a traditional pharmacokinetic study.
3. Active Control: Studies that compare a known and effective drug to the study drug.
4. Placebo Control: Studies that compare the study drug to an inactive substance or treatment that does not have any therapeutic activity.
5. Historical Control: Studies that use past information from studies or drug experience to compare with the effect of the study drug.
6. Blinded: During a blinded trial, the participant and/or investigators do not know what treatment the patient is receiving. “Double blinding” means that neither the investigator nor participant knows what treatment is being given. During a “single blinded” trial, the participant is unaware of the treatment, although the investigators know. Blinded studies help to minimize study bias regarding the efficacy and safety of the drug being studied.
7. Open Label: In such a study, participants and/or investigators may be aware of which treatment the participant is receiving.
8. Parallel Group: During a parallel group study, each treatment group is studied simultaneously. For example, in a controlled study, one group may receive the study drug while at the same time a second, separate group receives a placebo or alternative treatment.
9. Crossover: In such a study each patient serves as his/her own control and each treatment is examined sequentially. For example, in a single treatment, controlled study, Group 1 receives the study drug first while at the same time the other Group 2 receives a placebo or alternative treatment first. Then, Group 1 receives a placebo or alternative treatment while at the same time Group 2 receives the study drug.
10. Dose Response: A measure of the body's response to escalating drug doses. A dose response pattern usually shows little or no drug effect at very low dosages and increasing levels of effect or toxicity at higher doses until the effect plateaus. Usually, several doses of a drug are tested to find out which one is the safest and most effective.
11. Animal: Such studies are used to measure the potential toxicity of a drug. Animal studies are also performed when it would be unethical to test the drug in humans due to the nature of the disease or condition being studied (for example, bioterrorism agents such as anthrax).
12. Other: Any study that does not involve the study designs described above.
For more information regarding clinical trials, see:
http://www.fda.gov/oashi/clinicaltrials/clintrialdoc.html.