FDA — authorised 28 September 1972
- Application: NDA016968
- Marketing authorisation holder: ALCON
- Local brand name: MIOSTAT
- Indication: SOLUTION — INTRAOCULAR
- Status: approved
🇺🇸 Miostat in United States
FDA authorised Miostat on 28 September 1972
Marketing authorisations
FDA — authorised 28 April 1995
- Application: ANDA073677
- Marketing authorisation holder: NOVARTIS
- Local brand name: CARBASTAT
- Indication: SOLUTION — INTRAOCULAR
- Status: approved
FDA — authorised 28 January 2026
- Application: NDA220142
- Marketing authorisation holder: VISUS
- Indication: Type 3 - New Dosage Form and Type 4 - New Combination
- Status: approved
The FDA approved Miostat, a product of VISUS, on 28 January 2026. The approval was granted under the new dosage form and combination indication (Type 3 and Type 4, respectively). This approval was not granted through an expedited pathway.
FDA
- Application: ANDA070292
- Marketing authorisation holder: PHARMAFAIR
- Local brand name: CARBACHOL
- Indication: SOLUTION — INTRAOCULAR
- Status: approved
Miostat 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 Miostat approved in United States?
Yes. FDA authorised it on 28 September 1972; FDA authorised it on 28 April 1995; FDA authorised it on 28 January 2026.
Who is the marketing authorisation holder for Miostat in United States?
ALCON holds the US marketing authorisation.