FDA — authorised 21 April 2000
- Application: NDA021025
- Marketing authorisation holder: NOVARTIS
- Local brand name: EXELON
- Indication: SOLUTION — ORAL
- Status: approved
🇺🇸 Exelon in United States
FDA authorised Exelon on 21 April 2000 · 10,485 US adverse-event reports
Marketing authorisations
FDA — authorised 21 April 2000
- Application: NDA020823
- Marketing authorisation holder: NOVARTIS
- Local brand name: EXELON
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 6 July 2007
- Application: NDA022083
- Marketing authorisation holder: SANDOZ
- Local brand name: EXELON
- Indication: FILM, EXTENDED RELEASE — TRANSDERMAL
- Status: approved
FDA — authorised 31 August 2015
- Application: ANDA204403
- Marketing authorisation holder: ALVOGEN
- Local brand name: RIVASTIGMINE
- Indication: FILM, EXTENDED RELEASE — TRANSDERMAL
- Status: approved
FDA — authorised 20 June 2018
- Application: ANDA205622
- Marketing authorisation holder: MYLAN TECHNOLOGIES
- Local brand name: RIVASTIGMINE
- Indication: FILM, EXTENDED RELEASE — TRANSDERMAL
- Status: approved
FDA — authorised 4 March 2019
- Application: ANDA206318
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: RIVASTIGMINE
- Indication: FILM, EXTENDED RELEASE — TRANSDERMAL
- Status: approved
FDA — authorised 26 November 2019
- Application: ANDA209063
- Marketing authorisation holder: BRECKENRIDGE
- Local brand name: RIVASTIGMINE
- Indication: FILM, EXTENDED RELEASE — TRANSDERMAL
- 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.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 10,485
Most-reported reactions
- Death — 2,642 reports (25.2%)
- Fall — 1,408 reports (13.43%)
- Confusional State — 971 reports (9.26%)
- Pneumonia — 881 reports (8.4%)
- Vomiting — 881 reports (8.4%)
- Malaise — 833 reports (7.94%)
- Nausea — 757 reports (7.22%)
- Hallucination — 737 reports (7.03%)
- Drug Ineffective — 694 reports (6.62%)
- Dizziness — 681 reports (6.49%)
Exelon in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Neuroscience approved in United States
Frequently asked questions
Is Exelon approved in United States?
Yes. FDA authorised it on 21 April 2000; FDA authorised it on 21 April 2000; FDA authorised it on 6 July 2007.
Who is the marketing authorisation holder for Exelon in United States?
NOVARTIS holds the US marketing authorisation.