🇺🇸 Tabrecta in United States

FDA authorised Tabrecta on 6 May 2020

Marketing authorisation

FDA — authorised 6 May 2020

Application: NDA213591
Marketing authorisation holder: NOVARTIS PHARM
Local brand name: TABRECTA
Indication: TABLET — ORAL
Status: approved

The US FDA approved Tabrecta, a prescription medicine, for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) harbouring a specific mutation. This approval was based on a standard application pathway. Tabrecta is manufactured by Novartis Pharmaceuticals Corporation.

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Tabrecta in other countries

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

Other Oncology approved in United States

Frequently asked questions

Is Tabrecta approved in United States?

Yes. FDA authorised it on 6 May 2020.

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

NOVARTIS PHARM holds the US marketing authorisation.