FDA — authorised 9 February 2000
- Application: NDA021107
- Marketing authorisation holder: LEGACY PHARMA
- Local brand name: LOTRONEX
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Lotronex in United States
FDA authorised Lotronex on 9 February 2000
Marketing authorisations
FDA — authorised 18 October 2021
- Application: ANDA213614
- Marketing authorisation holder: MANKIND PHARMA
- Indication: REMS
- Status: approved
FDA — authorised 8 September 2023
- Application: ANDA206647
- Marketing authorisation holder: AMNEAL PHARMS
- Indication: REMS
- Status: approved
FDA — authorised 15 August 2025
- Application: ANDA211621
- Marketing authorisation holder: HIBROW HLTHCARE
- Indication: Manufacturing (CMC)
- Status: approved
The FDA approved the marketing authorisation for Lotronex, a pharmaceutical product, on 15 August 2025. The approval was granted to HIBROW HLTHCARE for the manufacturing (CMC) indication. This approval was made through the standard expedited pathway.
Lotronex 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 Lotronex approved in United States?
Yes. FDA authorised it on 9 February 2000; FDA authorised it on 18 October 2021; FDA authorised it on 8 September 2023.
Who is the marketing authorisation holder for Lotronex in United States?
LEGACY PHARMA holds the US marketing authorisation.