FDA — authorised 23 November 2010
- Application: NDA022504
- Marketing authorisation holder: ELI LILLY AND CO
- Local brand name: AXIRON
- Indication: SOLUTION, METERED — TRANSDERMAL
- Status: approved
🇺🇸 testosterone gel 2% in United States
FDA authorised testosterone gel 2% on 23 November 2010
Marketing authorisations
FDA
- Status: approved
testosterone gel 2% in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is testosterone gel 2% approved in United States?
Yes. FDA authorised it on 23 November 2010; FDA has authorised it.
Who is the marketing authorisation holder for testosterone gel 2% in United States?
ELI LILLY AND CO holds the US marketing authorisation.