FDA — authorised 15 May 2014
- Application: NDA204822
- Marketing authorisation holder: NOVARTIS
- Local brand name: IZBA
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
🇺🇸 Habitual prostaglandin monotherapy in United States
FDA authorised Habitual prostaglandin monotherapy on 15 May 2014
Marketing authorisations
FDA — authorised 7 July 2017
- Application: ANDA205050
- Marketing authorisation holder: MYLAN
- Local brand name: TRAVOPROST
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 20 December 2019
- Application: ANDA210458
- Marketing authorisation holder: ALEMBIC
- Local brand name: TRAVOPROST
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 19 March 2021
- Application: ANDA203767
- Marketing authorisation holder: MICRO LABS
- Local brand name: TRAVOPROST
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 3 May 2024
- Application: ANDA207040
- Marketing authorisation holder: LUPIN
- Local brand name: TRAVOPROST
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 12 July 2024
- Application: ANDA218159
- Marketing authorisation holder: GLAND
- Local brand name: TRAVOPROST
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 17 December 2025
- Application: ANDA214687
- Marketing authorisation holder: ALEMBIC
- Local brand name: TRAVOPROST
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
The FDA approved Alembic's TRAVOPROST for ophthalmic use as a prostaglandin monotherapy on 17 December 2025. This approval was granted under the standard expedited pathway. TRAVOPROST is indicated for use as a solution or drops for the treatment of a specific condition. The approval was based on an application number ANDA214687.
FDA
- Status: approved
Habitual prostaglandin monotherapy in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is Habitual prostaglandin monotherapy approved in United States?
Yes. FDA authorised it on 15 May 2014; FDA authorised it on 7 July 2017; FDA authorised it on 20 December 2019.
Who is the marketing authorisation holder for Habitual prostaglandin monotherapy in United States?
NOVARTIS holds the US marketing authorisation.