Opportunity
Federal Register #2026-21711
FDA corrections to regulatory review period determinations for six drug products
Buyer
Department of Health and Human Services / Food and Drug Administration
Posted
October 23, 2026
Identifier
2026-21711
The Food and Drug Administration issued corrections to regulatory review period determinations for six drug products.
Description
The FDA is correcting notices determining the regulatory review periods for patent extension purposes for ANDEMBRY, ANZUPGO, ANKTIVA, BIZENGRI, BRINSUPRI, and DAYVIGO. The original notices correctly stated when the testing and approval phases began and ended, but calculation errors resulted in incorrect regulatory review period lengths. The correction provides the applicable period lengths and their testing- and approval-phase breakdowns. Comment, redetermination-request, and due-diligence petition deadlines, as well as the dates used in the calculations, remain unchanged.