FDA — authorised 15 September 2017
- Marketing authorisation holder: SYMBIOMIX THERAPEUTICS LLC
- Status: approved
🇺🇸 Solosec in United States
FDA authorised Solosec on 15 September 2017
Marketing authorisations
FDA — authorised 15 September 2017
- Application: NDA209363
- Marketing authorisation holder: EVOFEM INC
- Local brand name: SOLOSEC
- Indication: GRANULE — ORAL
- Status: approved
Solosec 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 Solosec approved in United States?
Yes. FDA authorised it on 15 September 2017; FDA authorised it on 15 September 2017.
Who is the marketing authorisation holder for Solosec in United States?
SYMBIOMIX THERAPEUTICS LLC holds the US marketing authorisation.