🇺🇸 TELBIVUDINE in United States

FDA authorised TELBIVUDINE on 28 April 2009 · 429 US adverse-event reports

Marketing authorisations

FDA — authorised 28 April 2009

  • Application: NDA022154
  • Marketing authorisation holder: NOVARTIS
  • Local brand name: TYZEKA
  • Indication: SOLUTION — ORAL
  • Status: approved

Read official source →

FDA

  • 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.

Most-reported reactions

  1. Drug Resistance — 102 reports (23.78%)
  2. Blood Creatine Phosphokinase Increased — 55 reports (12.82%)
  3. Pathogen Resistance — 50 reports (11.66%)
  4. Myalgia — 42 reports (9.79%)
  5. Viral Mutation Identified — 38 reports (8.86%)
  6. Drug Ineffective — 35 reports (8.16%)
  7. Treatment Failure — 34 reports (7.93%)
  8. Muscular Weakness — 30 reports (6.99%)
  9. Foetal Exposure During Pregnancy — 22 reports (5.13%)
  10. Nausea — 21 reports (4.9%)

Source database →

TELBIVUDINE in other countries

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

Frequently asked questions

Is TELBIVUDINE approved in United States?

Yes. FDA authorised it on 28 April 2009; FDA has authorised it.

Who is the marketing authorisation holder for TELBIVUDINE in United States?

NOVARTIS holds the US marketing authorisation.