🇺🇸 SPD489 in United States

SPD489 (SPD489) regulatory status in United States.

Marketing authorisation

FDA

  • Status: approved

SPD489 in other countries

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

Other Other approved in United States

Frequently asked questions

Is SPD489 approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for SPD489 in United States?

Shire is the originator. The local marketing authorisation holder may differ — check the official source linked above.