🇺🇸 Extended Release Subcutaneous Buprenorphine in United States

FDA authorised Extended Release Subcutaneous Buprenorphine on 30 November 2017

Marketing authorisations

FDA — authorised 30 November 2017

  • Application: NDA209819
  • Marketing authorisation holder: INDIVIOR
  • Local brand name: SUBLOCADE
  • Indication: SOLUTION, EXTENDED RELEASE — SUBCUTANEOUS
  • Status: approved

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FDA

  • Status: approved

Extended Release Subcutaneous Buprenorphine 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 Extended Release Subcutaneous Buprenorphine approved in United States?

Yes. FDA authorised it on 30 November 2017; FDA has authorised it.

Who is the marketing authorisation holder for Extended Release Subcutaneous Buprenorphine in United States?

INDIVIOR holds the US marketing authorisation.