The Priority Review

Regulation Brief

FDA corrects patent extension review periods for six drugs

The FDA corrects the length of the regulatory review period for ANDEMBRY, ANZUPGO, ANKTIVA, BIZENGRI, BRINSUPRI, and DAYVIGO due to calculation errors. The corrections apply to determinations announced on August 10, August 17, and September 9, 2026; no other changes are made.

Primary source

Federal Register notice, October 23, 2026

Determination of Regulatory Review Period for Purposes of Patent Extension; Correction of Notices-ANDEMBRY; ANZUPGO; ANKTIVA; BIZENGRI; BRINSUPRI; DAYVIGO

Read the source: Determination of Regulatory Review Period for Purposes of Patent Extension; Correction of Notices-ANDEMBRY; ANZUPGO; ANKTIVA; BIZENGRI; BRINSUPRI; DAYVIGO federalregister.gov

Machine-summarized from the source above; not independently reported. How we use automation