FDA — authorised 1 April 1968
- Marketing authorisation holder: NOVARTIS
- Status: approved
🇺🇸 Desferal in United States
FDA authorised Desferal on 1 April 1968
Marketing authorisations
FDA — authorised 1 April 1968
- Application: NDA016267
- Marketing authorisation holder: MITEM PHARMA
- Local brand name: DESFERAL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 27 May 2011
- Application: ANDA078718
- Marketing authorisation holder: FRESENIUS KABI USA
- Indication: Labeling
- Status: approved
FDA — authorised 23 October 2023
- Application: ANDA076019
- Marketing authorisation holder: HOSPIRA
- Indication: Labeling
- Status: approved
FDA — authorised 5 February 2024
- Application: ANDA207384
- Marketing authorisation holder: GLAND
- Indication: Labeling
- Status: approved
The FDA approved Desferal, a product of GLAND, under the standard expedited pathway on February 5, 2024. The approval was granted for the drug's approved indication as stated in its labeling. The application number for this approval is ANDA207384.
Desferal in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Hematology approved in United States
Frequently asked questions
Is Desferal approved in United States?
Yes. FDA authorised it on 1 April 1968; FDA authorised it on 1 April 1968; FDA authorised it on 27 May 2011.
Who is the marketing authorisation holder for Desferal in United States?
NOVARTIS holds the US marketing authorisation.