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Inactive Ingredients Database Download

Data updated through July 2024

Quarterly Inactive Ingredient Database (IID) Change Log

Quarterly IID Change Log displays changes made since the previous quarterly IID publication.

FDA Approves First Treatment for Cerebrotendinous Xanthomatosis, a Rare Lipid Storage Disease

The FDA approved Ctexli (chenodiol) for the treatment of cerebrotendinous xanthomatosis (CTX) in adults. Ctexli is the first FDA-approved drug…

Patient Listening Session Summaries

Patient Listening Session summaries are published after each session to share a high-level summary of the discussion. The Public Engagement…

eCTD Submission Standards for eCTD v4.0 and Regional M1

A listing of the Implementation Guides, Specifications, and Documentation that support the FDA implementation for eCTD v4.0

Withdrawn | Non-malignant Hematological, Neurological, and Other Disorder Indications Accelerated Approvals

This listing includes accelerated approvals (AAs) for non-malignant hematological, neurological, and other disorder indications with postmarketing trials that have been subsequently withdrawn, and…

Identification of Hexahydrocannabiphorol Metabolites in Human Urine

This paper describes the detection of Phase I and Phase II metabolites of hexahydrocannabiphorol in urine after oral ingestion of…

Metabolic Profile of Etomidate and Its Three Analogs in Zebrafish, Human Liver Microsomes, Human Urine and Hair Samples Using UHPLC‐Q Exactive Orbitrap‐HRMS

Our study researched the metabolism of etomidate and its three analogs in zebrafish, HLMs, human urine and hair samples by…

Why the racing industry and equestrian disciplines need to implement population pharmacokinetics: To learn, explain, summarize, harmonize, and individualize

Population pharmacokinetics (POP PK) is a pharmacokinetic tool, which measures and explains the variability in drug exposure and drug effect…

Metabolism of highly potent synthetic opioid nitazene analogs: N‐ethyl‐N‐(1‐glucuronyloxyethyl) metabolite formation and degradation to N‐desethyl metabolites during enzymatic hydrolysis

This study revealed that nitazene analogs were mainly metabolized by N-1-hydroxylation followed by glucuronidation, N-deethylation, O-dealkylation followed by glucuronidation, and…