{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,17]],"date-time":"2026-08-17T23:16:55Z","timestamp":1787008615623,"version":"build-2736575974"},"reference-count":19,"publisher":"Oxford University Press (OUP)","issue":"12","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2021,12,16]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>Pathogenesis of neonatal candidiasis (NC) is distinct from systemic candidiasis in adults and older pediatric patients due to the significant incidence of central nervous system involvement in neonates. Thus, although adequate and well-controlled trials in NC are often unfeasible due to difficulty enrolling patients, extrapolation of efficacy from antifungal drug trials in adults is generally not appropriate. However, treatment of NC is an area of great unmet need. We describe a regulatory review approach that combined the assessment of limited clinical efficacy, pharmacokinetics, and safety data from neonates and young infants along with microbiology outcomes and pharmacokinetic data from relevant nonclinical models of candidemia\/invasive candidiasis to inform the use of micafungin in pediatric patients younger than 4 months, while communicating areas of remaining uncertainty in labeling.<\/jats:p>","DOI":"10.1093\/cid\/ciab025","type":"journal-article","created":{"date-parts":[[2021,1,15]],"date-time":"2021-01-15T15:26:03Z","timestamp":1610724363000},"page":"2335-2340","source":"Crossref","is-referenced-by-count":11,"title":["A Regulatory Review Approach for Evaluation of Micafungin for Treatment of Neonatal Candidiasis"],"prefix":"10.1093","volume":"73","author":[{"given":"Gillian","family":"Taormina","sequence":"first","affiliation":[{"name":"Division of Anti-Infectives, Office of Infectious Diseases, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ramya","family":"Gopinath","sequence":"additional","affiliation":[{"name":"Division of Anti-Infectives, Office of Infectious Diseases, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jason","family":"Moore","sequence":"additional","affiliation":[{"name":"Division of Infectious Disease Pharmacology, Office of Clinical Pharmacology, Office of Translational Sciences, Food and Drug Administration, Silver Spring, Maryland, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yuliya","family":"Yasinskaya","sequence":"additional","affiliation":[{"name":"Division of Anti-Infectives, Office of Infectious Diseases, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Philip","family":"Colangelo","sequence":"additional","affiliation":[{"name":"Division of Infectious Disease Pharmacology, Office of Clinical Pharmacology, Office of Translational Sciences, Food and Drug Administration, Silver Spring, Maryland, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kellie","family":"Reynolds","sequence":"additional","affiliation":[{"name":"Division of Infectious Disease Pharmacology, Office of Clinical Pharmacology, Office of Translational Sciences, Food and Drug Administration, Silver Spring, Maryland, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sumati","family":"Nambiar","sequence":"additional","affiliation":[{"name":"Division of Anti-Infectives, Office of Infectious Diseases, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, 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