FDA — authorised 19 November 2004
- Marketing authorisation holder: ASTELLAS
- Status: approved
🇺🇸 Vesicare in United States
FDA authorised Vesicare on 19 November 2004
Marketing authorisations
FDA — authorised 19 November 2004
- Application: NDA021518
- Marketing authorisation holder: ASTELLAS
- Local brand name: VESICARE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 20 May 2019
- Application: ANDA210281
- Marketing authorisation holder: BOSTAL
- Status: approved
FDA — authorised 20 May 2019
- Application: ANDA210224
- Marketing authorisation holder: ALKEM LABS LTD
- Status: approved
FDA — authorised 26 May 2020
- Application: NDA209529
- Marketing authorisation holder: ASTELLAS
- Indication: Type 3 - New Dosage Form
- Status: approved
FDA — authorised 24 November 2020
- Application: ANDA209239
- Marketing authorisation holder: GLENMARK SPECLT
- Indication: Labeling
- Status: approved
FDA — authorised 3 December 2021
- Application: ANDA211657
- Marketing authorisation holder: SCIEGEN PHARMS
- Indication: Labeling
- Status: approved
Vesicare in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Urology approved in United States
Frequently asked questions
Is Vesicare approved in United States?
Yes. FDA authorised it on 19 November 2004; FDA authorised it on 19 November 2004; FDA authorised it on 20 May 2019.
Who is the marketing authorisation holder for Vesicare in United States?
ASTELLAS holds the US marketing authorisation.