🇺🇸 Pylera in United States

FDA authorised Pylera on 28 September 2006

Marketing authorisations

FDA — authorised 28 September 2006

  • Application: NDA050786
  • Marketing authorisation holder: LABS JUVISE
  • Status: supplemented

FDA

  • Status: approved

Pylera in other countries

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

Other Other approved in United States

Frequently asked questions

Is Pylera approved in United States?

Yes. FDA authorised it on 28 September 2006; FDA has authorised it.

Who is the marketing authorisation holder for Pylera in United States?

LABS JUVISE holds the US marketing authorisation.