FDA — authorised 2 April 2001
- Application: ANDA075547
- Marketing authorisation holder: WEST-WARD PHARMS INT
- Local brand name: THIOTEPA
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 THIOTEPA in United States
FDA authorised THIOTEPA on 2 April 2001 · 5,850 US adverse-event reports
Marketing authorisations
FDA — authorised 26 January 2017
- Application: NDA208264
- Marketing authorisation holder: ADIENNE SA
- Local brand name: TEPADINA AND SODIUM CHLORIDE
- Indication: POWDER — INTRAVENOUS
- Status: approved
FDA — authorised 4 May 2018
- Application: ANDA209150
- Marketing authorisation holder: HENGRUI PHARMA
- Status: approved
FDA — authorised 8 December 2021
- Application: ANDA211831
- Marketing authorisation holder: REGCON HOLDINGS
- Local brand name: THIOTEPA
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 3 January 2022
- Application: ANDA214222
- Marketing authorisation holder: GLAND
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 5 September 2023
- Application: ANDA211755
- Marketing authorisation holder: HIKMA
- Local brand name: THIOTEPA
- Indication: POWDER — INTRACAVITARY, INTRAVENOUS, INTRAVESICAL
- Status: approved
FDA — authorised 26 December 2023
- Application: ANDA216037
- Marketing authorisation holder: MEITHEAL
- Local brand name: THIOTEPA
- Indication: POWDER — INTRACAVITARY, INTRAVENOUS, INTRAVESICAL
- Status: approved
FDA — authorised 30 May 2024
- Application: ANDA213049
- Marketing authorisation holder: MSN
- Indication: Labeling
- Status: approved
The FDA approved THIOTEPA for labeling indications. This approval was granted to MSN on 2024-05-30. The application number for this approval is ANDA213049.
FDA — authorised 25 June 2024
- Application: NDA216984
- Marketing authorisation holder: SHORLA
- Local brand name: TEPYLUTE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 5,850
Most-reported reactions
- Off Label Use — 1,039 reports (17.76%)
- Febrile Neutropenia — 753 reports (12.87%)
- Mucosal Inflammation — 740 reports (12.65%)
- Product Use In Unapproved Indication — 567 reports (9.69%)
- Cytomegalovirus Infection — 521 reports (8.91%)
- Drug Ineffective — 504 reports (8.62%)
- Pyrexia — 482 reports (8.24%)
- Acute Graft Versus Host Disease — 425 reports (7.26%)
- Acute Graft Versus Host Disease In Skin — 416 reports (7.11%)
- Infection — 403 reports (6.89%)
THIOTEPA in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is THIOTEPA approved in United States?
Yes. FDA authorised it on 2 April 2001; FDA authorised it on 26 January 2017; FDA authorised it on 4 May 2018.
Who is the marketing authorisation holder for THIOTEPA in United States?
WEST-WARD PHARMS INT holds the US marketing authorisation.