🇺🇸 Vyleesi (Autoinjector) in United States

FDA authorised Vyleesi (Autoinjector) on 21 June 2019

Marketing authorisations

FDA — authorised 21 June 2019

  • Application: NDA210557
  • Marketing authorisation holder: COSETTE
  • Local brand name: VYLEESI (AUTOINJECTOR)
  • Indication: SOLUTION — SUBCUTANEOUS
  • Status: approved

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FDA

  • Status: approved

Vyleesi (Autoinjector) in other countries

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

Other Neuroscience approved in United States

Frequently asked questions

Is Vyleesi (Autoinjector) approved in United States?

Yes. FDA authorised it on 21 June 2019; FDA has authorised it.

Who is the marketing authorisation holder for Vyleesi (Autoinjector) in United States?

COSETTE holds the US marketing authorisation.