FOI 25-0145 LD – Romidepsin For Injection

Written by Claude Haiku 4.5 from the extracted text on 27 Feb 2026. It can miss or misread redacted and scanned pages. Check the source before relying on it.

Istodax (romidepsin) 10mg powder for injection is a TGA-registered medicine (ARTG entry 198854) sponsored by Celgene Pty Ltd since 7 August 2013. The product comprises a composite pack of lyophilised powder for intravenous infusion with reconstitution solvent. It is indicated for treating peripheral T-cell lymphoma in patients who have received at least one prior systemic therapy. Classified as a Schedule 4 prescription-only medicine, the product has a 48-month shelf life when stored below 25 degrees Celsius in its original container. Registration is subject to standard conditions applying to registered therapeutic goods under the Therapeutic Goods Act 1989.