Gilead Sciences, Inc.: lenacapavir

We have identified deficiencies in the product quality information for the lenacapavir injection NDA 215973. As the approval of lenacapavir tablet is contingent on the approval of lenacapavir injection, the lenacapavir injection deficiencies must be adequately addressed before this application can be approved.

Therefore, we recommend including both options in labeling and other associated aspects of your application as needed to accommodate these regimens (e.g., alternative packaging configurations).

7. If, at the time of your resubmission, data from Cohort 2 of Study GS-US-2004625 are available, these data should be incorporated into your application and labeling.

1. Your data demonstrate that the drug product solution is incompatible with the proposed commercial borosilicate glass vials.

8. If, at the time of your resubmission, data from Cohort 2 of Study GS-US-2004625 are available, these data should be incorporated into your application and labeling.