FDA Corrects Review-Time Math for Six Unusually Named Medicines
Published Date: 10/23/2026
Notice
Summary
The FDA fixed some math mistakes in earlier announcements about how long it took to review six medicines, including BRINSUPRI and DAYVIGO. These corrections don’t change any deadlines or rules but make sure the official review times are accurate. If you’re involved with these drugs, no new actions or fees are needed—just updated info to keep things clear.
Analyzed Economic Effects
2 provisions identified: 2 benefits, 0 costs, 0 mixed.
Corrected review lengths for six drugs
On October 23, 2026, the FDA corrected the previously published regulatory review periods for six drugs. The corrected total review periods and testing/approval breakdowns are: BRINSUPRI — 2,925 days (2,681 testing; 244 approval); DAYVIGO — 3,116 days (2,648 testing; 468 approval); BIZENGRI — 2,912 days (2,636 testing; 276 approval); ANKTIVA — 3,925 days (3,224 testing; 701 approval); ANZUPGO — 3,535 days (3,169 testing; 366 approval); ANDEMBRY — 2,531 days (1,918 testing; 613 approval).
No changes to deadlines or fees
The FDA states that all due dates for submitting comments, redetermination requests, and petitions for due diligence remain the same as originally published, and no new actions or fees are required because of these corrections. The corrections only fix calculation errors and do not change any deadlines or other rules.
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