Inactive Written Requests

Approved active moieties for which the U.S. Food and Drug Administration (FDA) has issued a written request for pediatric studies in accordance with BPCA can also be found on the FDA website.

DRUG INDICATION
Azithromycin For the treatment of chlamydia trachomatis (CT) (PDF 60 KB)
Azithromycin For the treatment of ureaplasma urealyticum (PDF 51 KB)
Bupropion For the treatment of children with depression and for smoking cessation (PDF 469 KB)
Dactinomycin For the treatment of children with cancer (PDF 308 KB)
Daunomycin For treatment of acute lymphocytic leukemia and other malignancies in childhood (PDF 68 KB)
Dexrazoxane for injection For the treatment of children with cancer (PDF 242 KB)
Eletriptan For the acute treatment of migraine in adolescents 12 to 17 years of age with a history of migraine headaches (PDF 139 KB)
Griseofulvin For the treatment of tinea capitis (PDF 406 KB)
Hydrochlorothiazide For treatment of high blood pressure in pediatric patients (PDF 342 KB)
Hydrocortisone For treatment of atopic dermatitis (PDF 6.8 MB)
Isotretinoin For the treatment of children with high-risk neuroblastoma (PDF 156 KB)
Methotrexate For the treatment of acute lymphoblastic leukemia (PDF 49 KB)
Metoclopramide For the treatment of the signs and symptoms of gastroesophageal reflux disease (PDF 87 KB)
Morphine For analgesia in pediatric patients (PDF 632 KB)
Sevelamer For the treatment of chronic renal failure in pediatric patients (PDF 497 KB)
Vincristine For the treatment of children with cancer (PDF 229 KB)
Zonisamide For the treatment of children with partial seizures (PDF 665 KB)
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