FDA — authorised 29 January 2013
- Marketing authorisation holder: GENZYME CORP
- Status: approved
🇺🇸 Kynamro in United States
FDA authorised Kynamro on 29 January 2013
Marketing authorisations
FDA — authorised 29 January 2013
- Application: NDA203568
- Marketing authorisation holder: KASTLE THERAPS LLC
- Local brand name: KYNAMRO
- Indication: SOLUTION — SUBCUTANEOUS
- Status: approved
Kynamro in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Metabolic approved in United States
Frequently asked questions
Is Kynamro approved in United States?
Yes. FDA authorised it on 29 January 2013; FDA authorised it on 29 January 2013.
Who is the marketing authorisation holder for Kynamro in United States?
GENZYME CORP holds the US marketing authorisation.