Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
  • Print
  • Share
  • E-mail
-
Generic Name: adagrasib
Trade Name: Krazati
Date Designated: 06/07/2021
Orphan Designation: Treatment for KRAS G12C Positive NSCLC
Orphan Designation Status: Designated/Approved
Bristol-Myers Squibb Company
3401 Princeton Pike
Lawrenceville, New Jersey 08648
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: adagrasib
Trade Name: Krazati
Marketing Approval Date: 12/12/2022
Approved Labeled Indication: Treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, who have received at least one prior systemic therapy
Exclusivity End Date: 12/12/2029 
Exclusivity Protected Indication* :  Treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, who have received at least one prior systemic therapy
*Exclusivity Protected Indications are shown for approvals from 01/01/2013 to the present.
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
-
-