🇺🇸 Direct Acting Antivirals in United States

FDA authorised Direct Acting Antivirals on 27 January 2022 · 12 US adverse-event reports

Marketing authorisation

FDA — authorised 27 January 2022

  • Application: ANDA211353
  • Marketing authorisation holder: TEVA PHARMS USA INC
  • Local brand name: SOFOSBUVIR
  • 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. Hepatocellular Carcinoma — 4 reports (33.33%)
  2. Agitation — 1 report (8.33%)
  3. Amnesia — 1 report (8.33%)
  4. Aphasia — 1 report (8.33%)
  5. Blister — 1 report (8.33%)
  6. Confusional State — 1 report (8.33%)
  7. Dermatitis Allergic — 1 report (8.33%)
  8. Disorientation — 1 report (8.33%)
  9. Epilepsy — 1 report (8.33%)

Source database →

Direct Acting Antivirals in other countries

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

Other Virology/Infectious Disease approved in United States

Frequently asked questions

Is Direct Acting Antivirals approved in United States?

Yes. FDA authorised it on 27 January 2022.

Who is the marketing authorisation holder for Direct Acting Antivirals in United States?

TEVA PHARMS USA INC holds the US marketing authorisation.