🇺🇸 SPN-812 in United States

SPN-812 (SPN-812) regulatory status in United States.

Marketing authorisation

FDA

  • Status: approved

SPN-812 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 SPN-812 approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for SPN-812 in United States?

Supernus Pharmaceuticals, Inc. is the originator. The local marketing authorisation holder may differ — check the official source linked above.