FDA — authorised 17 July 2017
- Application: NDA208051
- Marketing authorisation holder: PUMA BIOTECH
- Local brand name: NERLYNX
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 NERATINIB MALEATE in United States
FDA authorised NERATINIB MALEATE on 17 July 2017
Marketing authorisations
FDA
- Status: approved
FDA
- Application: ANDA216236
- Marketing authorisation holder: SANDOZ INC
- Local brand name: NERATINIB MALEATE
- Indication: TABLET — ORAL
- Status: approved
NERATINIB MALEATE 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 NERATINIB MALEATE approved in United States?
Yes. FDA authorised it on 17 July 2017; FDA has authorised it; FDA has authorised it.
Who is the marketing authorisation holder for NERATINIB MALEATE in United States?
PUMA BIOTECH holds the US marketing authorisation.