FDA — authorised 27 September 1990
- Status: approved
🇺🇸 Idamycin Pfs in United States
FDA authorised Idamycin Pfs on 27 September 1990
Marketing authorisations
FDA — authorised 14 December 2006
- Application: ANDA065275
- Marketing authorisation holder: HIKMA
- Status: approved
FDA — authorised 27 April 2020
- Application: ANDA065036
- Marketing authorisation holder: MEITHEAL
- Indication: Labeling
- Status: approved
FDA — authorised 6 February 2026
- Application: NDA050734
- Marketing authorisation holder: PFIZER
- Indication: Labeling
- Status: approved
The FDA approved Idamycin Pfs, a product of Pfizer, for its approved labeling on February 6, 2026. This approval was granted through the standard expedited pathway. Idamycin Pfs is a pharmaceutical product, but the specific local brand name is not reported.
Idamycin Pfs 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 Idamycin Pfs approved in United States?
Yes. FDA authorised it on 27 September 1990; FDA authorised it on 14 December 2006; FDA authorised it on 27 April 2020.
Who is the marketing authorisation holder for Idamycin Pfs in United States?
Marketing authorisation holder not available in our data.