FDA — authorised 10 December 1964
- Application: NDA050682
- Marketing authorisation holder: RECORDATI RARE
- Local brand name: COSMEGEN
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Cosmegen in United States
FDA authorised Cosmegen on 10 December 1964
Marketing authorisations
FDA — authorised 10 December 1964
- Marketing authorisation holder: RECORDATI RARE
- Status: approved
FDA — authorised 16 March 2010
- Application: ANDA090304
- Marketing authorisation holder: HIKMA
- Local brand name: DACTINOMYCIN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 23 August 2013
- Application: ANDA202562
- Marketing authorisation holder: AM REGENT
- Local brand name: DACTINOMYCIN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 9 November 2017
- Application: ANDA203385
- Marketing authorisation holder: EUGIA PHARMA
- Local brand name: DACTINOMYCIN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 20 May 2019
- Application: ANDA203999
- Marketing authorisation holder: XGEN PHARMS
- Local brand name: DACTINOMYCIN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 16 July 2019
- Application: ANDA207232
- Marketing authorisation holder: HISUN PHARM HANGZHOU
- Local brand name: DACTINOMYCIN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 13 November 2020
- Application: ANDA213463
- Marketing authorisation holder: MEITHEAL
- Local brand name: DACTINOMYCIN
- Indication: INJECTABLE — INJECTION
- Status: approved
Cosmegen 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 Cosmegen approved in United States?
Yes. FDA authorised it on 10 December 1964; FDA authorised it on 10 December 1964; FDA authorised it on 16 March 2010.
Who is the marketing authorisation holder for Cosmegen in United States?
RECORDATI RARE holds the US marketing authorisation.