🇺🇸 Selegiline Transdermal System in United States

FDA authorised Selegiline Transdermal System on 27 February 2006 · 113 US adverse-event reports

Marketing authorisations

FDA — authorised 27 February 2006

  • Application: NDA021336
  • Marketing authorisation holder: SOMERSET
  • Local brand name: EMSAM
  • Indication: FILM, EXTENDED RELEASE — TRANSDERMAL
  • Status: approved

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FDA — authorised 27 February 2006

  • Application: NDA021708
  • Marketing authorisation holder: SOMERSET
  • Local brand name: EMSAM
  • Indication: SYSTEM — TRANSDERMAL
  • 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. Depression — 18 reports (15.93%)
  2. Application Site Erythema — 17 reports (15.04%)
  3. Drug Ineffective — 13 reports (11.5%)
  4. Insomnia — 12 reports (10.62%)
  5. Application Site Pruritus — 10 reports (8.85%)
  6. Anxiety — 9 reports (7.96%)
  7. Drug Effect Decreased — 9 reports (7.96%)
  8. Nausea — 9 reports (7.96%)
  9. Dizziness — 8 reports (7.08%)
  10. Headache — 8 reports (7.08%)

Source database →

Frequently asked questions

Is Selegiline Transdermal System approved in United States?

Yes. FDA authorised it on 27 February 2006; FDA authorised it on 27 February 2006; FDA has authorised it.

Who is the marketing authorisation holder for Selegiline Transdermal System in United States?

SOMERSET holds the US marketing authorisation.