FDA — authorised 25 October 2005
- Application: BLA021716
- Marketing authorisation holder: AKORN INC
- Local brand name: HYDASE
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 SC HYLENEX and Ceftriaxone in United States
FDA authorised SC HYLENEX and Ceftriaxone on 25 October 2005
Marketing authorisations
FDA — authorised 2 December 2005
- Application: BLA021859
- Marketing authorisation holder: HALOZYME THERAP
- Local brand name: HYLENEX RECOMBINANT
- Indication: INJECTABLE — INJECTION
- Status: approved
SC HYLENEX and Ceftriaxone in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is SC HYLENEX and Ceftriaxone approved in United States?
Yes. FDA authorised it on 25 October 2005; FDA authorised it on 2 December 2005.
Who is the marketing authorisation holder for SC HYLENEX and Ceftriaxone in United States?
AKORN INC holds the US marketing authorisation.