FDA — authorised 29 March 2006
- Application: ANDA077208
- Marketing authorisation holder: SLATE RUN PHARMA
- Status: approved
🇺🇸 Silicea in United States
FDA authorised Silicea on 29 March 2006
Marketing authorisations
FDA — authorised 12 November 2015
- Application: NDA022015
- Marketing authorisation holder: BAYER HEALTHCARE LLC
- Indication: Labeling
- Status: approved
FDA — authorised 16 November 2022
- Application: ANDA210181
- Marketing authorisation holder: CONCORD BIOTECH LTD
- Indication: Labeling
- Status: approved
FDA — authorised 28 July 2023
- Application: ANDA211212
- Marketing authorisation holder: AMNEAL
- Indication: Labeling
- Status: approved
FDA — authorised 23 September 2025
- Application: NDA022405
- Marketing authorisation holder: GENZYME CORP
- Indication: REMS
- Status: approved
The FDA approved Silicea, manufactured by Genzyme Corp, for a Risk Evaluation and Mitigation Strategy (REMS). The approval was granted on September 23, 2025, under the standard expedited pathway. The REMS indication for Silicea is not specified in the available information.
FDA
- Marketing authorisation holder: UNIQUE
- Status: approved
Silicea in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in United States
Frequently asked questions
Is Silicea approved in United States?
Yes. FDA authorised it on 29 March 2006; FDA authorised it on 12 November 2015; FDA authorised it on 16 November 2022.
Who is the marketing authorisation holder for Silicea in United States?
SLATE RUN PHARMA holds the US marketing authorisation.