🇺🇸 optimized background therapy in United States

FDA authorised optimized background therapy on 6 August 2007

Marketing authorisations

FDA — authorised 6 August 2007

  • Application: NDA022128
  • Marketing authorisation holder: VIIV HLTHCARE
  • Local brand name: SELZENTRY
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 4 November 2016

  • Application: NDA208984
  • Marketing authorisation holder: VIIV HLTHCARE
  • Local brand name: SELZENTRY
  • Indication: SOLUTION — ORAL
  • Status: approved

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Frequently asked questions

Is optimized background therapy approved in United States?

Yes. FDA authorised it on 6 August 2007; FDA authorised it on 4 November 2016.

Who is the marketing authorisation holder for optimized background therapy in United States?

VIIV HLTHCARE holds the US marketing authorisation.