🇺🇸 Oral RPV in United States

FDA authorised Oral RPV on 29 January 2026

Marketing authorisations

FDA — authorised 29 January 2026

  • Application: ANDA218798
  • Marketing authorisation holder: SOMERSET THERAPS LLC
  • Local brand name: RILPIVIRINE
  • Indication: TABLET
  • Status: approved

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FDA

  • Application: ANDA205302
  • Marketing authorisation holder: STRIDES ARCOLAB LTD
  • Local brand name: RILPIVIRINE
  • Indication: TABLET — ORAL
  • Status: approved

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Other Infectious Disease approved in United States

Frequently asked questions

Is Oral RPV approved in United States?

Yes. FDA authorised it on 29 January 2026; FDA has authorised it.

Who is the marketing authorisation holder for Oral RPV in United States?

SOMERSET THERAPS LLC holds the US marketing authorisation.