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Regulatory news: Dojolvi (triheptanoin) as a source of calories and fatty acids in long-chain fatty acid oxidation disorders: FDA approval summary.
Zand, Dina; Doan, Jenny; Yi, Sojeong; Wang, Jie; Ma, Lian; Akinshola, Emmanuel; Chakder, Sushanta; Meyer, Joette; Pacanowski, Michael; Johnson, Laura Lee; Donohue, Kathleen; Beitz, Julie.
Afiliação
  • Zand D; Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
  • Doan J; Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
  • Yi S; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
  • Wang J; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
  • Ma L; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
  • Akinshola E; Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
  • Chakder S; Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
  • Meyer J; Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
  • Pacanowski M; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
  • Johnson LL; Office of Biostatistics, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
  • Donohue K; Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
  • Beitz J; Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
J Inherit Metab Dis ; 44(3): 515-517, 2021 05.
Article em En | MEDLINE | ID: mdl-33729583
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Oxirredução / Triglicerídeos / Ácidos Graxos / Erros Inatos do Metabolismo Lipídico Idioma: En Ano de publicação: 2021 Tipo de documento: Article
Texto completo
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XML
PubMed Links
Buscar no Google

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Oxirredução / Triglicerídeos / Ácidos Graxos / Erros Inatos do Metabolismo Lipídico Idioma: En Ano de publicação: 2021 Tipo de documento: Article