Regulatory PathRegulatory requirements compared

Active substance

Deoxycholic acid

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
BELKYRA 10MG/ML SOLUTION FOR INJECTION10 mg/mlInjection · Subcutaneous use4 VialSAR 3603.60NCE · PrescriptionAllergan IncWithdrawn by MAH · Not Marketed

US FDA United States — FDA approvals (Drugs@FDA)

ProductStrengthForm · routeApplicantStatusFirst approved
KYBELLA20MG/2ML (10MG/ML)solution · subcutaneousABBVIEPrescription29 Apr 2015
DEOXYCHOLIC ACID20MG/2ML (10MG/ML)solution · subcutaneousWILSHIRE PHARMS INCPrescription2 Apr 2021

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
BELKYRA0244391010 MG / MLSOLUTION · SUBCUTANEOUSABBVIE CORPORATION

Safety signals and safety-related labeling changes

  • US FDA 11 Sep 2026 KYBELLA — safety-related labeling change
    Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for deoxycholic acid →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.