🇺🇸 Duloxetine 60mg in United States

FDA authorised Duloxetine 60mg on 3 August 2004 · 122 US adverse-event reports

Marketing authorisations

FDA — authorised 3 August 2004

  • Application: NDA021427
  • Marketing authorisation holder: LILLY
  • Local brand name: CYMBALTA
  • Indication: CAPSULE, DELAYED REL PELLETS — ORAL
  • Status: approved

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FDA — authorised 3 September 2004

  • Application: NDA021733
  • Marketing authorisation holder: LILLY
  • Local brand name: CYMBALTA
  • Indication: CAPSULE, DELAYED REL PELLETS — ORAL
  • Status: approved

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FDA — authorised 13 June 2008

  • Application: NDA022148
  • Marketing authorisation holder: LILLY
  • Local brand name: CYMBALTA
  • Indication: CAPSULE, DELAYED REL PELLETS — ORAL
  • Status: approved

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FDA — authorised 4 November 2010

  • Application: NDA022516
  • Marketing authorisation holder: LILLY
  • Local brand name: CYMBALTA
  • Indication: CAPSULE, DELAYED REL PELLETS — ORAL
  • Status: approved

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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. Product Substitution Issue — 24 reports (19.67%)
  2. Depression — 19 reports (15.57%)
  3. Dizziness — 16 reports (13.11%)
  4. Anxiety — 12 reports (9.84%)
  5. Headache — 12 reports (9.84%)
  6. Nausea — 11 reports (9.02%)
  7. Suicidal Ideation — 8 reports (6.56%)
  8. Insomnia — 7 reports (5.74%)
  9. Product Quality Issue — 7 reports (5.74%)
  10. Diarrhoea — 6 reports (4.92%)

Source database →

Duloxetine 60mg 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 Duloxetine 60mg approved in United States?

Yes. FDA authorised it on 3 August 2004; FDA authorised it on 3 September 2004; FDA authorised it on 13 June 2008.

Who is the marketing authorisation holder for Duloxetine 60mg in United States?

LILLY holds the US marketing authorisation.