Regulatory PathRegulatory requirements compared

Active substance

Talc

Open in the medicines table

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

ProductStrengthForm · routeApplicantStatusFirst approved
SCLEROSOL4GM/SPRAYaerosol · intrapleuralSCIARRA LABSPrescription24 Dec 1997
TALC5GM/BOTpowder · intrapleuralSCIARRA LABSPrescription15 Dec 2003
STERITALC2GM/VIAL; 3GM/VIAL; 4GM/VIALpowder · intrapleuralNOVATECH SAPrescription1 May 2017

Safety signals and safety-related labeling changes

All safety entries for talc →

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.