FDA — authorised 9 June 2009
- Application: ANDA090270
- Marketing authorisation holder: MYLAN INSTITUTIONAL
- Status: approved
🇺🇸 Alkeran in United States
FDA authorised Alkeran on 9 June 2009
Marketing authorisations
FDA — authorised 28 May 2019
- Application: ANDA209826
- Marketing authorisation holder: GLAND
- Status: approved
FDA — authorised 18 August 2023
- Application: NDA217110
- Marketing authorisation holder: APOTEX
- Indication: Type 3 - New Dosage Form
- Status: approved
FDA — authorised 29 October 2024
- Application: ANDA206523
- Marketing authorisation holder: AVET LIFESCIENCES
- Status: approved
FDA — authorised 4 September 2025
- Application: NDA201848
- Marketing authorisation holder: DELCATH SYSTEMS INC
- Indication: REMS
- Status: approved
The FDA approved Alkeran, a medication, for a Risk Evaluation and Mitigation Strategy (REMS) indication. This approval was granted to DELCATH SYSTEMS INC on September 4, 2025, following a standard expedited pathway. The application number for this approval is NDA201848.
Alkeran in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Oncology approved in United States
Frequently asked questions
Is Alkeran approved in United States?
Yes. FDA authorised it on 9 June 2009; FDA authorised it on 28 May 2019; FDA authorised it on 18 August 2023.
Who is the marketing authorisation holder for Alkeran in United States?
MYLAN INSTITUTIONAL holds the US marketing authorisation.