Regulatory news: Dojolvi (triheptanoin) as a source of calories and fatty acids in long-chain fatty acid oxidation disorders: FDA approval summary

J Inherit Metab Dis. 2021 May;44(3):515-517. doi: 10.1002/jimd.12377. Epub 2021 Mar 25.

Authors

Affiliations

¹ Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
² Office of Clinical Pharmacology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
³ Office of Biostatistics, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.

PMID: 33729583
DOI: 10.1002/jimd.12377

No abstract available

Publication types

Editorial
News

MeSH terms

Adolescent
Adult
Child
Double-Blind Method
Drug Approval
Fatty Acids* / metabolism
Female
Humans
Lipid Metabolism, Inborn Errors* / drug therapy
Lipid Metabolism, Inborn Errors* / metabolism
Male
Middle Aged
Oxidation-Reduction* / drug effects
Randomized Controlled Trials as Topic
Triglycerides* / administration & dosage
United States
United States Food and Drug Administration
Young Adult

Substances

Fatty Acids
Triglycerides
triheptanoin