FDA — authorised 19 March 1987
- Marketing authorisation holder: VIIV HLTHCARE
- Status: approved
🇺🇸 Retrovir in United States
FDA authorised Retrovir on 19 March 1987
Marketing authorisations
FDA — authorised 13 May 2009
- Application: ANDA078128
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Indication: Labeling
- Status: approved
FDA — authorised 5 May 2017
- Application: ANDA077558
- Marketing authorisation holder: AUROBINDO PHARMA
- Status: approved
FDA — authorised 29 August 2018
- Application: ANDA090679
- Marketing authorisation holder: MACLEODS PHARMS LTD
- Status: approved
FDA — authorised 10 February 2020
- Application: ANDA077267
- Marketing authorisation holder: AUROBINDO
- Indication: Labeling
- Status: approved
FDA — authorised 18 December 2024
- Application: NDA019655
- Marketing authorisation holder: VIIV HLTHCARE
- Indication: Labeling
- Status: approved
The FDA approved Retrovir, a medication developed by VIIV HLTHCARE, on 18 December 2024. The approval was granted under the standard expedited pathway. The drug's indication for use is labelled, but the specific local brand name is not reported.
Retrovir 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 Retrovir approved in United States?
Yes. FDA authorised it on 19 March 1987; FDA authorised it on 13 May 2009; FDA authorised it on 5 May 2017.
Who is the marketing authorisation holder for Retrovir in United States?
VIIV HLTHCARE holds the US marketing authorisation.