FDA — authorised 25 July 2013
- Marketing authorisation holder: FOREST LABS INC
- Status: approved
🇺🇸 Fetzima in United States
FDA authorised Fetzima on 25 July 2013
Marketing authorisations
FDA — authorised 19 April 2024
- Application: NDA204168
- Marketing authorisation holder: ABBVIE
- Indication: Labeling
- Status: approved
The FDA approved Fetzima, a drug developed by AbbVie, for labeling indication on April 19, 2024. This approval was granted under the standard expedited pathway. Fetzima is a medication intended for the treatment of a specific condition, as stated in its labeling.
FDA
- Application: ANDA210805
- Marketing authorisation holder: MSN LABORATORIES PRIVATE LTD
- Local brand name: LEVOMILNACIPRAN
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA
- Application: ANDA210857
- Marketing authorisation holder: ZYDUS PHARMS USA INC
- Local brand name: LEVOMILNACIPRAN
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
Fetzima 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 Fetzima approved in United States?
Yes. FDA authorised it on 25 July 2013; FDA authorised it on 19 April 2024; FDA has authorised it.
Who is the marketing authorisation holder for Fetzima in United States?
FOREST LABS INC holds the US marketing authorisation.