🇺🇸 Dolutegravir/Lamivudine in United States

FDA authorised Dolutegravir/Lamivudine on 8 April 2019 · 495 US adverse-event reports

Marketing authorisation

FDA — authorised 8 April 2019

  • Application: NDA211994
  • Marketing authorisation holder: VIIV HLTHCARE
  • Local brand name: DOVATO
  • Indication: TABLET — ORAL
  • Status: approved

Read official source →

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.

Most-reported reactions

  1. Foetal Exposure During Pregnancy — 131 reports (26.46%)
  2. Nephropathy Toxic — 66 reports (13.33%)
  3. Exposure During Pregnancy — 56 reports (11.31%)
  4. Congenital Umbilical Hernia — 52 reports (10.51%)
  5. Abortion Spontaneous — 45 reports (9.09%)
  6. Maternal Exposure During Pregnancy — 39 reports (7.88%)
  7. Pathogen Resistance — 30 reports (6.06%)
  8. Renal Failure — 26 reports (5.25%)
  9. Acute Kidney Injury — 25 reports (5.05%)
  10. Neurotoxicity — 25 reports (5.05%)

Source database →

Dolutegravir/Lamivudine in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Infectious Disease / Virology approved in United States

Frequently asked questions

Is Dolutegravir/Lamivudine approved in United States?

Yes. FDA authorised it on 8 April 2019.

Who is the marketing authorisation holder for Dolutegravir/Lamivudine in United States?

VIIV HLTHCARE holds the US marketing authorisation.