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Product safetyFDAUnited StatesImports

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

23 October 2026

In plain English

FDA corrects regulatory review period determinations for patent extension purposes covering ANDEMBRY, ANZUPGO, ANKTIVA, BIZENGRI, BRINSUPRI and DAYVIGO.

Read the official notice
Topic
Product safety
Regulator
FDA
Published
23 October 2026
For
Imports
Where it applies
United States
Source
FDA (Food and Drug Administration)

From the notice

The Food and Drug Administration (FDA) is announcing corrections to the notices of Determination of Regulatory Review Period for Purposes of Patent Extension for ANDEMBRY; ANZUPGO; ANKTIVA; BIZENGRI; BRINSUPRI; and DAYVIGO. The original determinations were announced in the Federal Registers of August 10, 2026 (BRINSUPRI, DAYVIGO), August 17, 2026 (BIZENGRI), and September 9, 2026 (ANDEMBRY, ANZUPGO, ANKTIVA). Those notices correctly identified the dates on which the testing and approval phase
The full text is at the source

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