🇺🇸 Orbactiv in United States

FDA authorised Orbactiv on 6 August 2014 · 858 US adverse-event reports

Marketing authorisations

FDA — authorised 6 August 2014

  • Application: NDA206334
  • Marketing authorisation holder: MELINTA THERAP
  • Local brand name: ORBACTIV
  • Indication: POWDER — INTRAVENOUS
  • 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. Off Label Use — 164 reports (19.11%)
  2. Pruritus — 152 reports (17.72%)
  3. Urticaria — 102 reports (11.89%)
  4. Rash — 82 reports (9.56%)
  5. Back Pain — 71 reports (8.28%)
  6. Chills — 64 reports (7.46%)
  7. Dyspnoea — 60 reports (6.99%)
  8. Nausea — 59 reports (6.88%)
  9. Erythema — 57 reports (6.64%)
  10. Chest Pain — 47 reports (5.48%)

Source database →

Orbactiv 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 approved in United States

Frequently asked questions

Is Orbactiv approved in United States?

Yes. FDA authorised it on 6 August 2014; FDA has authorised it.

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

MELINTA THERAP holds the US marketing authorisation.