FDA — authorised 19 March 1987
- Application: NDA019655
- Marketing authorisation holder: VIIV HLTHCARE
- Local brand name: RETROVIR
- Indication: CAPSULE — ORAL
- Status: approved
🇺🇸 ZDV+3TC+LPV/r in United States
FDA authorised ZDV+3TC+LPV/r on 19 March 1987 · 3 US adverse-event reports
Marketing authorisations
FDA — authorised 28 September 1989
- Application: NDA019910
- Marketing authorisation holder: VIIV HLTHCARE
- Local brand name: RETROVIR
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 2 February 1990
- Application: NDA019951
- Marketing authorisation holder: VIIV HLTHCARE
- Local brand name: RETROVIR
- Indication: INJECTABLE — INJECTION
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 22 April 2025 – 22 April 2026
- Total reports: 3
Most-reported reactions
- Foetal Exposure During Pregnancy — 1 report (33.33%)
- Maternal Drugs Affecting Foetus — 1 report (33.33%)
- Neonatal Asphyxia — 1 report (33.33%)
Other Infectious Disease / Virology approved in United States
Frequently asked questions
Is ZDV+3TC+LPV/r approved in United States?
Yes. FDA authorised it on 19 March 1987; FDA authorised it on 28 September 1989; FDA authorised it on 2 February 1990.
Who is the marketing authorisation holder for ZDV+3TC+LPV/r in United States?
VIIV HLTHCARE holds the US marketing authorisation.