FDA — authorised 29 June 1994
- Marketing authorisation holder: NOVARTIS
- Status: approved
🇺🇸 Famvir in United States
FDA authorised Famvir on 29 June 1994
Marketing authorisations
FDA — authorised 29 June 1994
- Application: NDA020363
- Marketing authorisation holder: NOVARTIS
- Local brand name: FAMVIR
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 24 August 2007
- Application: ANDA077487
- Marketing authorisation holder: TEVA PHARMS
- Local brand name: FAMCICLOVIR
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 21 March 2011
- Application: ANDA090128
- Marketing authorisation holder: HIKMA
- Local brand name: FAMCICLOVIR
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 21 March 2011
- Application: ANDA091114
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: FAMCICLOVIR
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 21 March 2011
- Application: ANDA078278
- Marketing authorisation holder: CIPLA
- Local brand name: FAMCICLOVIR
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 24 March 2011
- Application: ANDA201333
- Marketing authorisation holder: NATCO PHARMA
- Local brand name: FAMCICLOVIR
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 July 2011
- Application: ANDA091480
- Marketing authorisation holder: APOTEX
- Local brand name: FAMCICLOVIR
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 12 January 2012
- Application: ANDA201022
- Marketing authorisation holder: MACLEODS PHARMS LTD
- Local brand name: FAMCICLOVIR
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 September 2014
- Application: ANDA202438
- Marketing authorisation holder: HETERO LABS LTD V
- Local brand name: FAMCICLOVIR
- Indication: TABLET — ORAL
- Status: approved
Famvir in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Immunology approved in United States
Frequently asked questions
Is Famvir approved in United States?
Yes. FDA authorised it on 29 June 1994; FDA authorised it on 29 June 1994; FDA authorised it on 24 August 2007.
Who is the marketing authorisation holder for Famvir in United States?
NOVARTIS holds the US marketing authorisation.