🇺🇸 Nplate in United States

FDA authorised Nplate on 22 August 2008

Marketing authorisations

FDA — authorised 22 August 2008

  • Marketing authorisation holder: AMGEN
  • Status: approved

FDA — authorised 22 August 2008

  • Application: BLA125268
  • Marketing authorisation holder: AMGEN
  • Local brand name: NPLATE
  • Indication: INJECTABLE — SUBCUTANEOUS
  • Status: approved

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Nplate in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Cardiovascular approved in United States

Frequently asked questions

Is Nplate approved in United States?

Yes. FDA authorised it on 22 August 2008; FDA authorised it on 22 August 2008.

Who is the marketing authorisation holder for Nplate in United States?

AMGEN holds the US marketing authorisation.