FDA — authorised 7 November 2019
- Application: NDA212279
- Marketing authorisation holder: GISKIT
- Local brand name: EXEM FOAM KIT
- Indication: FOAM — INTRAUTERINE
- Status: approved
FDA authorised Exem Foam Kit on 7 November 2019
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 7 November 2019.
GISKIT holds the US marketing authorisation.