FDA — authorised 24 December 1997
- Application: NDA020587
- Marketing authorisation holder: SCIARRA LABS
- Local brand name: SCLEROSOL
- Indication: AEROSOL — INTRAPLEURAL
- Status: approved
🇺🇸 Sclerosol in United States
FDA authorised Sclerosol on 24 December 1997
Marketing authorisations
FDA — authorised 15 December 2003
- Application: NDA021388
- Marketing authorisation holder: SCIARRA LABS
- Local brand name: TALC
- Indication: POWDER — INTRAPLEURAL
- Status: approved
FDA — authorised 1 May 2017
- Application: NDA205555
- Marketing authorisation holder: NOVATECH SA
- Local brand name: STERITALC
- Indication: POWDER — INTRAPLEURAL
- Status: approved
FDA
- Status: approved
Sclerosol in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Infectious Disease approved in United States
Frequently asked questions
Is Sclerosol approved in United States?
Yes. FDA authorised it on 24 December 1997; FDA authorised it on 15 December 2003; FDA authorised it on 1 May 2017.
Who is the marketing authorisation holder for Sclerosol in United States?
SCIARRA LABS holds the US marketing authorisation.