🇺🇸 TOBI® PODHALER® in United States

FDA authorised TOBI® PODHALER® on 22 March 2013

Marketing authorisations

FDA — authorised 22 March 2013

  • Application: NDA201688
  • Marketing authorisation holder: VIATRIS
  • Local brand name: TOBI PODHALER
  • Indication: POWDER — INHALATION
  • Status: approved

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FDA

  • Status: approved

TOBI® PODHALER® 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 TOBI® PODHALER® approved in United States?

Yes. FDA authorised it on 22 March 2013; FDA has authorised it.

Who is the marketing authorisation holder for TOBI® PODHALER® in United States?

VIATRIS holds the US marketing authorisation.