FDA — authorised 28 August 2009
- Application: NDA022257
- Marketing authorisation holder: CHEPLAPHARM
- Local brand name: VALCYTE
- Indication: FOR SOLUTION — ORAL
- Status: approved
FDA authorised Innovative Valganciclovir on 28 August 2009
Yes. FDA authorised it on 28 August 2009.
CHEPLAPHARM holds the US marketing authorisation.