FDA — authorised 4 November 1999
- Application: NDA020498
- Marketing authorisation holder: ANI PHARMS
- Indication: Manufacturing (CMC)
- Status: approved
🇺🇸 Casodex in United States
FDA authorised Casodex on 4 November 1999
Marketing authorisations
FDA — authorised 30 June 2011
- Application: ANDA079110
- Marketing authorisation holder: SUN PHARM
- Indication: Labeling
- Status: approved
FDA — authorised 21 June 2012
- Application: ANDA079089
- Marketing authorisation holder: ADAPTIS
- Indication: Labeling
- Status: approved
FDA — authorised 19 March 2024
- Application: ANDA078917
- Marketing authorisation holder: ACCORD HLTHCARE
- Indication: Labeling
- Status: approved
The FDA approved Casodex for the treatment of prostate cancer. The approval was granted to ACCORD HLTHCARE on 19 March 2024, under the standard expedited pathway. The application number for this approval is ANDA078917.
Casodex 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 Casodex approved in United States?
Yes. FDA authorised it on 4 November 1999; FDA authorised it on 30 June 2011; FDA authorised it on 21 June 2012.
Who is the marketing authorisation holder for Casodex in United States?
ANI PHARMS holds the US marketing authorisation.