🇺🇸 New formulation in United States

New formulation (New formulation) regulatory status in United States.

Marketing authorisation

FDA

  • Status: approved

New formulation 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 New formulation approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for New formulation in United States?

GlaxoSmithKline is the originator. The local marketing authorisation holder may differ — check the official source linked above.