Regulatory PathRegulatory requirements compared

Active substance

Selenious acid

Open in the medicines table

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

ProductStrengthForm · routeApplicantStatusFirst approved
SELENIOUS ACIDEQ 600MCG SELENIUM/10ML (EQ 60MCG SELENIUM/ML); EQ 60MCG SELENIUM/ML (EQ 60MCG SELENIUM/ML); EQ 12MCG SELENIUM/2ML (EQ 6MCG SELENIUM/ML)solution · intravenousAM REGENTPrescription30 Apr 2019
SELENIOUS ACIDEQ 600MCG SELENIUM/10ML (EQ 60MCG SELENIUM/ML)solution · intravenousSUN PHARMPrescription20 Feb 2025
SELENIOUS ACIDEQ 12MCG SELENIUM/2ML (EQ 6MCG SELENIUM/ML); EQ 600MCG SELENIUM/10ML (EQ 60MCG SELENIUM/ML)solution · intravenousASPIROPrescription11 Jun 2025
SELENIOUS ACIDEQ 600MCG SELENIUM/10ML (EQ 60MCG SELENIUM/ML)solution · intravenousGLANDPrescription8 Jul 2025
SELENIOUS ACIDEQ 60MCG SELENIUM/ML (EQ 60MCG SELENIUM/ML); EQ 600MCG SELENIUM/10ML (EQ 60MCG SELENIUM/ML)solution · intravenousSTIRAPrescription31 Dec 2025
SELENIOUS ACIDEQ 600MCG SELENIUM/10ML (EQ 60MCG SELENIUM/ML)solution · intravenousEMERGE BIOSCIENCEPrescription3 Feb 2026
SELENIOUS ACIDEQ 12MCG SELENIUM/2ML (EQ 6MCG SELENIUM/ML); EQ 60MCG SELENIUM/ML (EQ 60MCG SELENIUM/ML); EQ 600MCG SELENIUM/10ML (EQ 60MCG SELENIUM/ML)solution · intravenousZYDUS PHARMSPrescription30 Jun 2026
SELENIOUS ACIDEQ 600MCG SELENIUM/10ML (EQ 60MCG SELENIUM/ML)solution · intravenousFRESENIUS KABI USADiscontinued10 Feb 2025
SELENIOUS ACIDEQ 12MCG SELENIUM/2ML (EQ 6MCG SELENIUM/ML); EQ 600MCG SELENIUM/10ML (EQ 60MCG SELENIUM/ML)solution · intravenousCIPLADiscontinued21 Jul 2025

Safety signals and safety-related labeling changes

All safety entries for selenious 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.