Drugs with granted exclusivity for pediatric studies under Section 505A of the Federal Food, Drug, and Cosmetic Act
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ABCDEFGHI
1
INNOriginal Brand nameDate of ExclusivityYear of exclusivitySponsorOriginal written requestIndication(s)Indication(s) shortNotes written by the FDA
2
Imiquimod12/13/200620063MMolluscum contagiosumMolluscum contagiosum
3
Remifentanil3/15/20002000AbbottAnestheticAnesthetic
4
Sevoflurane8/2/20002000AbbottAnestheticAnesthetic
5
Calcitriol2/16/20012001AbbottHypocalcemia management in patients on hemodialysisHypocalcemia
6
Paricalcitol12/8/20032003AbbottEnd Stage Renal DiseaseRenal disease
7
Sibutramine10/6/20042004AbbottPediatric ObesityObesity
8
RitonavirNorvir6/14/20052005AbbottHIV-1 InfectionHIV
9
Valproic acid12/14/20072007AbbottMigraine, Bipolar disorder, EpilepsyMigraine, Bipolar disorder, Epilepsy
10
Lopinavir/RitonavirKaletra3/7/20082008Abbotthttps://www.fda.gov/media/71284/downloadHIV-1 InfectionHIV
This is the first period of Pediatric Exclusivity for lopinavir and a second period for ritonavir.
11
Nelfinavir9/4/20032003AgouronHIV-1 InfectionHIV
12
Ciprofloxacin Ophth1/10/20032003AlconBacterial conjunctivitisConjunctivitis
13
Moxifloxacin Ophth1/10/20032003AlconBacterial conjunctivitisConjunctivitis
14
Brinzolamide6/28/20062006AlconElevated intraocular pressureIntraocular pressure
15
Levobetaxolol6/28/20062006AlconElevated intraocular pressureIntraocular pressure
16
Timolol2/28/20072007AlconElevated intraocular pressureIntraocular pressure
17
Olopatadine8/12/20092009Alconhttps://www.fda.gov/media/79810/downloadAllergic rhinitisRhinitis
18
Difluprednate3/21/20132013Alconhttps://www.fda.gov/media/85687/downloadPost-operative inflammation following cataract surgeryPost-operative inflammation
19
FinafloxacinXtoro8/25/20142014Alconhttps://www.fda.gov/media/89537/downloadAcute otitis externa (AOE)Acute otitis externa
20
Olopatadine12/16/20142014Alconhttps://www.fda.gov/media/90610/downloadAllergic conjunctivitisConjunctivitis
A second period of Pediatric Exclusivity was granted for this moiety.
21
Ketorolac9/6/20012001AllerganItching associated with allergic conjunctivitisConjunctivitis
22
Brimonidine10/10/20012001AllerganLower intraocular pressureIntraocular pressure
23
Ofloxacin3/12/20032003AllerganBacterial conjunctivitisConjunctivitis
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Gatifloxacin5/19/20092009Allerganhttps://www.fda.gov/media/76478/downloadBacterial conjunctivitis in peds 0 - 1 month of ageConjunctivitis
25
Oxybutynin2/8/20022002AlzaDetrusor hyperreflexiaHyperreflexia
26
Fentanyl1/29/20032003AlzaChronic painChronic pain
27
Ivabradine3/30/20192019AmgenCardiomyopathycardiomyopathy
28
Tavaborole7/18/20182018Anacorhttps://www.fda.gov/media/115355/downloadOnychomycosis of the toenailOnychomycosis
29
Azelastine8/11/19991999AstaItching associated with allergic conjunctivitisConjunctivitis
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Solifenacin7/20/20172017Astellashttps://www.fda.gov/media/107053/downloadNeurogenic detrusor overactivity (NDO)Neurogenic detrusor overactivity
31
Omeprazole5/1/20012001AstraZenecaGastro-esophageal refluxGastro-esophageal reflux
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Felodipine8/30/20012001AstraZenecaHypertensionHypertension
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Lisinopril11/19/20012001AstraZenecaHypertensionHypertension
34
Tamoxifen5/16/20022002AstraZenecaMcCune-Albright SyndromeMcCune-Albright Syndrome
35
Budesonide11/12/20022002AstraZenecaAsthma & allergic rhinitisAsthma & Rhinitis
36
Zolmitriptan12/18/20032003AstraZenecaMigraineMigraine
37
Metoprolol7/27/20062006AstraZenecaHypertensionHypertension
38
Anastrozole11/14/20072007AstraZenecahttps://www.fda.gov/media/71590/downloadMale pubertal patients with gynecomastia and female pediatric patients with McCune-Albright syndrome with progressive precocious puberty.McCune-Albright Syndrome
39
Bicalutamide9/19/20082008AstraZenecahttps://www.fda.gov/media/71858/downloadGonadotropin-independent precocious puberty in boys with testotoxicosis
Gonadotropin-independent precocious puberty
40
Quetiapine1/23/20092009AstraZenecahttps://www.fda.gov/media/75247/downloadSchizophrenia and bipolar maniaSchizophrenia and bipolar disorder
41
EsomeprazoleNexium5/1/20092009AstraZenecahttps://www.fda.gov/media/76415/downloadTreatment of gastroesophageal reflux disease (GERD)GERD
A second period of Pediatric Exclusivity was granted for this moiety.
42
Rosuvastatin7/7/20092009AstraZenecahttps://www.fda.gov/media/76967/downloadAdjunct to diet to reduce cholesterol and ApoB levelsReduce cholesterol and ApoB
43
Candesartan7/20/20092009AstraZenecahttps://www.fda.gov/media/77153/downloadReduce blood pressureHigh blood pressure
44
Fulvestrant2/1/20112011AstraZenecahttps://www.fda.gov/media/79840/downloadProgressive precocious puberty in girls with McCune-Albright SyndromeMcCune-Albright Syndrome
45
Budesonide/ Formoterol1/25/20172017AstraZenecahttps://www.fda.gov/media/102765/downloadAsthmaAsthma
46
Insulin Glargine7/12/19991999AventisDiabetes MellitusDiabetes
47
Fexofenadine1/27/20032003AventisAllergic rhinitis/urticariaRhinitis & urticaria
48
Leflunomide11/10/20032003AventisJRAJRA
49
Glimepiride6/9/20052005AventisType II DiabetesDiabetes
50
Loteprednol/Tobramycin12/28/20102010Bausch & Lombhttps://www.fda.gov/media/79729/downloadSuperficial bacterial ocular infectionOcular infection
51
Esmolol8/22/20032003BaxterHypertensionHypertension
52
Desflurane9/13/20062006BaxterAnesthesiaAnesthesia
53
CiprofloxacinCIPRO12/18/20032003BayerComplicated UTI, Acute pyelonephritisAcute pyelonephritis
54
Fludarabine4/3/20032003BerlexRefractory/relapse acute leukemiaLeukemia
55
Sotalol1/6/20002000Berlex LabArrhythmiasArrhythmias
56
Sapropterin3/13/20142014BioMarinhttps://www.fda.gov/media/88338/downloadReduce blood phenylalanine (Phe) levels in patients with hyperphenylalaninemia (HPA) due to BH4-responsive phenylketonuria (PKU)Reduce blood phenylalanine
57
Glyburide/Metformin10/8/20032003BMSDiabetes MellitusDiabetes
This is the first period of Pediatric Exclusivity for glyburide and a second period for metformin.
58
Carboplatin4/30/20042004BMSRefractory tumorsTumors
59
Technetium Tc99 sestamibi1/11/20082008BMShttps://www.fda.gov/media/71625/downloadKawasaki’s diseaseKawasaki’s disease
60
Ixabepilone4/5/20112011BMShttps://www.fda.gov/media/80244/downloadSolid TumorsTumors
61
Efavirenz1/29/20132013BMShttps://www.fda.gov/media/85111/downloadHIV-1 InfectionHIV
62
Entecavir12/5/20132013BMShttps://www.fda.gov/media/87484/downloadChronic Hepatitis B Virus InfectionHepatitis B
63
Abatacept2/14/20172017BMShttps://www.fda.gov/media/103220/downloadPolyarticular juvenile idiopathic arthritis (pJIA)Arthritis
64
IpilimumabYervoy7/20/20172017BMShttps://www.fda.gov/media/106997/downloadUnresectable or metastatic melanomaMelanoma
65
DasatinibSprycel9/27/20182018BMSPhiladelphia chromosome positive (Ph+) leukemias, including acute lymphoblastic leukemia (ALL) & chronic myeloid leukemia (CML)Leukemia
66
NevirapineNevirapine12/17/20012001Boehringer IngelheimPerinatal transmission of HIV infectionHIV
67
Meloxicam4/15/20052005Boehringer IngelheimJRAJRA
68
Tipranavir3/7/20082008Boehringer Ingelheimhttps://www.fda.gov/media/71369/downloadHIV-1 InfectionHIV
69
Tamsulosin9/17/20092009Boehringer Ingelheimhttps://www.fda.gov/media/78045/downloadElevated detrusor leak point pressure associated w/ a known neurological disorder (e.g., spina bifida)Neurological disorder
70
Tiotropium12/14/20162016Boehringer Ingelheimhttps://www.fda.gov/media/102215/downloadAsthmaAsthma
71
Metformin3/15/20002000Bristol-MyersDiabetes MellitusDiabetes
72
Buspirone5/22/20002000Bristol-MyersGeneralized anxiety disorderAnxiety disorder
73
Didanosine8/13/20012001Bristol-MyersHIV-1 InfectionHIV
74
StavudineZerit8/13/20012001Bristol-MyersHIV-1 InfectionHIV
75
Nefazodone6/27/20022002Bristol-MyersDepressionDepression
76
PravastatinPravachol7/10/20022002Bristol-MyersHypercholesterolemiaHypercholesterolemia
77
Fosinopril1/27/20032003Bristol-Myers SquibbHypertensionHypertension
78
Atazanavir6/23/20152015Bristol-Myers Squibbhttps://www.fda.gov/media/92643/downloadHIV-1 InfectionHIV
79
Modafinil3/21/20062006CephalonNarcolepsyNarcolepsy
80
Bendamustine5/24/20122012Cephalonhttps://www.fda.gov/media/83605/downloadRelapsed or refractory acute leukemiaLeukemia
81
Sunitinib2/7/20192019CP Pharmaceutical sRefractory solid & CNS tumorsTumors
82
Colesevelam2/17/20092009Daiichi Sankyohttps://www.fda.gov/media/75343/downloadHeterozygous familial hypercholesterolemia (heFH)Hypercholesterolemia
83
Olmesartan10/7/20092009Daiichi Sankyohttps://www.fda.gov/media/78067/downloadHypertension in pediatric patients 1– 16 years of ageHypertension
84
Rabeprazole12/4/20122012Eisaihttps://www.fda.gov/media/85217/downloadHealing & maintenance of healing of GERD & improvement of GERD symptomsGERD
85
Rufinamide1/13/20152015Eisaihttps://www.fda.gov/media/90133/downloadAdjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS)Seizures
86
Pemetrexed12/3/20102010Eli Lillyhttps://www.fda.gov/media/80043/downloadRefractory and recurrent solid tumors, including osteosarcoma, Ewing sarcoma/peripheral PNET, rhabdomyosarcoma, and neuroblastomaTumors
87
Duloxetine7/2/20122012Eli Lillyhttps://www.fda.gov/media/83825/downloadMajor depressive disorder (MDD)Depression
88
Prasugrel5/23/20162016Eli Lillyhttps://www.fda.gov/media/98405/downloadVaso-occlusive crises (VOC) in pediatric patients with sickle cell disease (SCD)Vaso-occlusive crises
89
TadalafilCialis11/16/20172017Eli Lillyhttps://www.fda.gov/media/109413/downloadDuchenne muscular dystrophy (DMD)Duchenne muscular dystrophy
90
Betaxolol2/28/20072007FalconElevated intraocular pressureIntraocular pressure
A second period of Pediatric Exclusivity was granted for this moiety (effective 6/07 when it received Hatch-Waxman exclusivity)
91
Citalopram7/12/20022002ForestDepressionDepression
92
Memantine6/16/20142014Forest Labshttps://www.fda.gov/media/88437/downloadAutism & Autism Spectrum Disorder (ASD)Autism
93
Asenapine3/3/20152015Forest Labshttps://www.fda.gov/media/91103/downloadSchizophrenia & bipolar disorderSchizophrenia and bipolar disorder
94
Tocilizumab7/18/20182018Genentech/ Hoffmann-La Rochehttps://www.fda.gov/media/115367/downloadSystemic Juvenile Idiopathic Arthritis (SJIA) and Polyarticular Course Juvenile Idiopathic Arthritis (PcJIA)Arthritis
95
Emtricitabine5/24/20062006GileadHIV-1 InfectionHIV
96
Tenofovir9/6/20112011GileadHIV-1 InfectionHIV
97
Tenofovir11/15/20182018Gileadhttps://www.fda.gov/media/118889/downloadHBV InfectionHepatitis B
A second period of Pediatric Exclusivity was granted for this moiety.
98
Abacavir12/14/19981998GlaxoHIV InfectionHIV
99
Ranitidine1/19/19991999GlaxoGastro-esophageal refluxGastro-esophageal reflux
100
Lamivudine9/22/20002000GlaxoHIV-1 InfectionHIV
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