FDA — authorised 27 June 2023
- Marketing authorisation holder: PFIZER IRELAND PHARMACEUTICALS
- Status: approved
🇺🇸 Ngenla in United States
FDA authorised Ngenla on 27 June 2023
Marketing authorisations
FDA — authorised 27 June 2023
- Application: BLA761184
- Marketing authorisation holder: PFIZER IRELAND PHARMACEUTICALS
- Local brand name: NGENLA
- Indication: INJECTABLE — INJECTION
- Status: approved
The FDA approved Ngenla, a recombinant human hyaluronidase injection, for subcutaneous administration for the treatment of pediatric patients with short stature. The approval was granted to Pfizer Ireland Pharmaceuticals under the standard expedited pathway. The application number for this approval is BLA761184.
Ngenla 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 Ngenla approved in United States?
Yes. FDA authorised it on 27 June 2023; FDA authorised it on 27 June 2023.
Who is the marketing authorisation holder for Ngenla in United States?
PFIZER IRELAND PHARMACEUTICALS holds the US marketing authorisation.