FDA — authorised 12 October 2007
- Application: NDA022145
- Marketing authorisation holder: MSD SUB MERCK
- Local brand name: ISENTRESS
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Raltegravir Film-coated Tablet in United States
FDA authorised Raltegravir Film-coated Tablet on 12 October 2007
Marketing authorisations
FDA — authorised 21 December 2011
- Application: NDA203045
- Marketing authorisation holder: MSD SUB MERCK
- Local brand name: ISENTRESS
- Indication: TABLET, CHEWABLE — ORAL
- Status: approved
FDA — authorised 20 December 2013
- Application: NDA205786
- Marketing authorisation holder: MSD SUB MERCK
- Local brand name: ISENTRESS
- Indication: POWDER — ORAL
- Status: approved
Frequently asked questions
Is Raltegravir Film-coated Tablet approved in United States?
Yes. FDA authorised it on 12 October 2007; FDA authorised it on 21 December 2011; FDA authorised it on 20 December 2013.
Who is the marketing authorisation holder for Raltegravir Film-coated Tablet in United States?
MSD SUB MERCK holds the US marketing authorisation.