FDA — authorised 17 September 2004
- Application: NDA021756
- Marketing authorisation holder: BAUSCH AND LOMB INC
- Local brand name: MACUGEN
- Indication: INJECTABLE — INTRAVITREAL
- Status: approved
🇺🇸 Macugen in United States
FDA authorised Macugen on 17 September 2004
Marketing authorisations
FDA
- Status: approved
Macugen in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Ophthalmology approved in United States
Frequently asked questions
Is Macugen approved in United States?
Yes. FDA authorised it on 17 September 2004; FDA has authorised it.
Who is the marketing authorisation holder for Macugen in United States?
BAUSCH AND LOMB INC holds the US marketing authorisation.