🇺🇸 CAL-101 in United States

FDA authorised CAL-101 on 17 February 2026

Marketing authorisation

FDA — authorised 17 February 2026

Application: ANDA216921
Marketing authorisation holder: NATCO
Local brand name: IDELALISIB
Indication: TABLET — ORAL
Status: approved

The FDA approved NATCO's new drug application (ANDA216921) for IDELALISIB (CAL-101) on 17 February 2026. This approval allows NATCO to market IDELALISIB as an oral tablet for a specific indication. The approval was granted through the standard expedited pathway.

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Other Oncology approved in United States

Frequently asked questions

Is CAL-101 approved in United States?

Yes. FDA authorised it on 17 February 2026.

Who is the marketing authorisation holder for CAL-101 in United States?

NATCO holds the US marketing authorisation.