🇺🇸 Intranasal Testosterone in United States

FDA authorised Intranasal Testosterone on 28 May 2014

Marketing authorisations

FDA — authorised 28 May 2014

  • Application: NDA205488
  • Marketing authorisation holder: ACERUS
  • Local brand name: NATESTO
  • Indication: GEL, METERED — NASAL
  • Status: approved

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FDA

  • Status: approved

Intranasal Testosterone 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 Intranasal Testosterone approved in United States?

Yes. FDA authorised it on 28 May 2014; FDA has authorised it.

Who is the marketing authorisation holder for Intranasal Testosterone in United States?

ACERUS holds the US marketing authorisation.