🇺🇸 MILNACIPRAN in United States

FDA authorised MILNACIPRAN on 14 January 2009 · 1,116 US adverse-event reports

Marketing authorisations

FDA — authorised 14 January 2009

  • Application: NDA022256
  • Marketing authorisation holder: ABBVIE
  • Status: supplemented

FDA — authorised 27 January 2016

  • Application: ANDA205071
  • Marketing authorisation holder: BRECKENRIDGE
  • Status: approved

FDA — authorised 3 October 2024

  • Application: ANDA205147
  • Marketing authorisation holder: HETERO LABS LTD V
  • Status: approved

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. Nausea — 143 reports (12.81%)
  2. Drug Ineffective — 140 reports (12.54%)
  3. Vomiting — 136 reports (12.19%)
  4. Pain — 120 reports (10.75%)
  5. Off Label Use — 116 reports (10.39%)
  6. Headache — 106 reports (9.5%)
  7. Drug Interaction — 103 reports (9.23%)
  8. Memory Impairment — 88 reports (7.89%)
  9. Hypoaesthesia — 83 reports (7.44%)
  10. Paraesthesia — 81 reports (7.26%)

Source database →

MILNACIPRAN 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 MILNACIPRAN approved in United States?

Yes. FDA authorised it on 14 January 2009; FDA authorised it on 27 January 2016; FDA authorised it on 3 October 2024.

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

ABBVIE holds the US marketing authorisation.