FDA — authorised 10 December 2015
- Application: ANDA204827
- Marketing authorisation holder: ALKEM LABS LTD
- Local brand name: FESOTERODINE FUMARATE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
🇺🇸 Toviaz in United States
FDA authorised Toviaz on 10 December 2015
Marketing authorisations
FDA — authorised 3 October 2017
- Application: ANDA204946
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: FESOTERODINE FUMARATE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 13 August 2019
- Application: ANDA204975
- Marketing authorisation holder: DR REDDYS
- Local brand name: FESOTERODINE FUMARATE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
The FDA approved Toviaz for labeling indication on August 27, 2024. This approval was granted to DR REDDYS under the standard expedited pathway. The application number for this approval is ANDA204975.
FDA — authorised 4 January 2023
- Application: ANDA204973
- Marketing authorisation holder: ALEMBIC
- Local brand name: FESOTERODINE FUMARATE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
The FDA approved Toviaz for labeling indication on July 26, 2024. This approval was granted to ALEMBIC under the standard expedited pathway. The application number for this approval is ANDA204973.
FDA — authorised 4 January 2023
- Application: ANDA204504
- Marketing authorisation holder: ANI PHARMS
- Local brand name: FESOTERODINE FUMARATE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 4 January 2023
- Application: ANDA204868
- Marketing authorisation holder: ACTAVIS LABS FL INC
- Local brand name: FESOTERODINE FUMARATE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 5 January 2023
- Application: ANDA204983
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: FESOTERODINE FUMARATE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 9 January 2024
- Application: ANDA204792
- Marketing authorisation holder: HETERO LABS LTD V
- Local brand name: FESOTERODINE FUMARATE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 28 February 2024
- Application: NDA022030
- Marketing authorisation holder: PFIZER
- Indication: Labeling
- Status: approved
The FDA approved Toviaz, a medication manufactured by Pfizer, on February 28, 2024. The approval was granted through a standard expedited pathway, with application number NDA022030. The approved indication for Toviaz is its labeling, which is not specified in the available information.
FDA — authorised 4 November 2024
- Application: ANDA205002
- Marketing authorisation holder: AMNEAL PHARMS NY
- Indication: Labeling
- Status: approved
The FDA approved Toviaz for labeling indications on November 4, 2024. The marketing authorization holder is AMNEAL PHARMS NY. This approval was granted under the standard expedited pathway.
FDA
- Application: ANDA204844
- Marketing authorisation holder: SANDOZ INC
- Local brand name: FESOTERODINE FUMARATE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
Toviaz in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Metabolic approved in United States
Frequently asked questions
Is Toviaz approved in United States?
Yes. FDA authorised it on 10 December 2015; FDA authorised it on 3 October 2017; FDA authorised it on 13 August 2019.
Who is the marketing authorisation holder for Toviaz in United States?
ALKEM LABS LTD holds the US marketing authorisation.