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

Issuing agencies

Abstract

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 phases began and ended but incorrectly stated the length of the regulatory review period due to calculation errors. No other changes are made.

Full Text

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<title>Federal Register, Volume 91 Issue 204 (Friday, October 23, 2026)</title>
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[Federal Register Volume 91, Number 204 (Friday, October 23, 2026)]
[Notices]
[Page 66851]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-21711]



[[Page 66851]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2025-E-3595; FDA-2025-E-3596; FDA-2025-E-3939; FDA-
2024-E-4125; FDA-2024-E-4128; FDA-2024-E-4129; FDA-2024-E-4130; FDA-
2024-E-4131; FDA-2025-E-0485; FDA-2025-E-0486; FDA-2025-E-0488; FDA-
2025-E-0489; FDA-2025-E-0490; FDA-2025-E-5206; and FDA-2025-E-0707]


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; correction.

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SUMMARY: 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 phases began and ended but incorrectly 
stated the length of the regulatory review period due to calculation 
errors. No other changes are made.

DATES: All due dates for submission of comments, redetermination 
requests, and submission of petitions for due diligence as well as the 
dates used to determine the regulatory review periods for the products 
noted above remain the same as originally published.

FOR FURTHER INFORMATION CONTACT: Patrick Clouser, Office of the 
Commissioner, Food and Drug Administration, 240-402-5276.

SUPPLEMENTARY INFORMATION: FDA announced the regulatory review period 
determination for BRINSUPRI in the Federal Register of August 10, 2026 
(91 FR 51493). In Document No. 2026-16247, on page 51494, second 
column, in the first paragraph of section II., the Determination of 
Regulatory Review Period portion of the document, the following 
correction is made:
    FDA has determined that the applicable regulatory review period for 
BRINSUPRI is 2,925 days. Of this time, 2,681 days occurred during the 
testing phase of the regulatory review period, while 244 days occurred 
during the approval phase.
    FDA announced the regulatory review period determination for 
DAYVIGO in the Federal Register of August 10, 2026 (91 FR 51494). In 
Document No. 2026-16246, on page 51495, third column, in the first 
paragraph of section II., the Determination of Regulatory Review Period 
portion of the document, the following correction is made:
    FDA has determined that the applicable regulatory review period for 
DAYVIGO is 3,116 days. Of this time, 2,648 days occurred during the 
testing phase of the regulatory review period, while 468 days occurred 
during the approval phase.
    FDA announced the regulatory review period determination for 
BIZENGRI in the Federal Register of August 17, 2026 (91 FR 53261). In 
Document No. 2026-16713, on page 53262, second column, in the first 
paragraph of section II., the Determination of Regulatory Review Period 
portion of the document, the following correction is made:
    FDA has determined that the applicable regulatory review period for 
BIZENGRI is 2,912 days. Of this time, 2,636 days occurred during the 
testing phase of the regulatory review period, while 276 days occurred 
during the approval phase.
    FDA announced the regulatory review period determination for 
ANKTIVA in the Federal Register of September 9, 2026 (91 FR 57350). In 
Document No. 2026-18297, on page 57351, third column, in the first 
paragraph of section II., the Determination of Regulatory Review Period 
portion of the document, the following correction is made:
    FDA has determined that the applicable regulatory review period for 
ANKTIVA is 3,925 days. Of this time, 3,224 days occurred during the 
testing phase of the regulatory review period, while 701 days occurred 
during the approval phase.
    FDA announced the regulatory review period determination for 
ANZUPGO in the Federal Register of September 9, 2026 (91 FR 57355). In 
Document No. 2026-18298, on page 57356, first column, in the first 
paragraph of section II., the Determination of Regulatory Review Period 
portion of the document, the following correction is made:
    FDA has determined that the applicable regulatory review period for 
ANZUPGO is 3,535 days. Of this time, 3,169 days occurred during the 
testing phase of the regulatory review period, while 366 days occurred 
during the approval phase.
    FDA announced the regulatory review period determination for 
ANDEMBRY in the Federal Register of September 9, 2026 (91 FR 57356). In 
Document No. 2026-18300, on page 57357, third column, in the first 
paragraph of section II., the Determination of Regulatory Review Period 
portion of the document, the following correction is made:
    FDA has determined that the applicable regulatory review period for 
ANDEMBRY is 2,531 days. Of this time, 1,918 days occurred during the 
testing phase of the regulatory review period, while 613 days occurred 
during the approval phase.

Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-21711 Filed 10-22-26; 8:45 am]
BILLING CODE 4164-01-P


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