Document ID: FDA-2020-E-2336-0007
Agency: fda
Document Type: Notice
Title: Determination of Regulatory Review Period for Purposes of Patent Extension; ROZLYTREK INJECTION; Correction
Posted Date: 2023-11-17T05:00Z

[Federal Register Volume 88, Number 221 (Friday, November 17, 2023)]
[Notices]
[Pages 80317-80318]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-25489]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2020-E-2333; FDA-2020-E-2334; FDA-2020-E-2336; and 
FDA-2020-E-2337]

Determination of Regulatory Review Period for Purposes of Patent 
Extension; ROZLYTREK INJECTION; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; correction.

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SUMMARY: The Food and Drug Administration (FDA) is correcting a notice 
that appeared in the Federal Register of July 8, 2022. The document 
announced the determination of the regulatory review period for 
ROZLYTREK INJECTION (entrectinib) for purposes of patent extension. The 
document was published with an incorrect dosage form. This notice 
corrects the dosage form of the drug product.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory 
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600.

SUPPLEMENTARY INFORMATION:

Correction

    In the Federal Register of July 8, 2022 (87 FR 40849), the dosage 
form for the human drug product ROZLYTREK (entrectinib), NDA 212726, is 
corrected from ``INJECTION'' to ``CAPSULES'' for all instances 
mentioned in the notice. Specifically, the drug product dosage form is 
corrected from ``INJECTION'' to ``CAPSULES'' in the following 
locations:
    1. On page 40849, the following corrections are made:
     In the second column, the title of the document is 
corrected to read: ``Determination of Regulatory Review Period for 
Purposes of Patent Extension; ROZLYTREK CAPSULES.''
     In the second column, the first sentence under the SUMMARY 
section is corrected to read: ``The Food and Drug Administration (FDA 
or the Agency) has determined the regulatory review period for 
ROZLYTREK CAPSULES and is publishing this notice of that determination 
as required by law.''
     In the third column, the first sentence under the section 
Instructions is corrected to read: ``All submissions received must 
include the Docket Nos. FDA-2020-E-2333; FDA-2020-E-2334; FDA-2020-E-
2336; and FDA-2020-E-2337 for `Determination of Regulatory Review 
Period for Purposes of Patent Extension; ROZLYTREK CAPSULES.'''
    2. On page 40850, the following corrections are made:
     In the second column, under section I. Background of the 
SUPPLEMENTARY INFORMATION section, the third paragraph introduction is 
corrected to read: ``FDA has approved for marketing the human drug 
product, ROZLYTREK CAPSULES (entrectinib), NDA 212726, indicated for 
the treatment of:''
     In the second and third columns, under section I. 
Background of the SUPPLEMENTARY INFORMATION section, the last paragraph 
is corrected to read: ``Subsequent to this approval, the USPTO received 
patent term restoration applications for ROZLYTREK CAPSULES (U.S. 
Patent Nos. 8,299,057; 8,673,893; 9,029,356; and 9,085,565) from 
Genentech, Inc., and the USPTO requested FDA's assistance in 
determining the patents' eligibility for patent term restoration. In a 
letter dated March 1, 2021, FDA advised the USPTO that this human drug 
product had undergone a regulatory review period and that the approval 
of ROZLYTREK CAPSULES represented the first permitted commercial 
marketing or use of the product. Thereafter, the USPTO requested that 
FDA determine the product's regulatory review period.''
     In the third column, under II. Determination of Regulatory 
Review Period, the first sentence of the introductory paragraph is 
corrected to read: ``FDA has determined that the applicable regulatory 
review period for ROZLYTREK CAPSULES is 1,968 days.''
     In the third column, under II. Determination of Regulatory 
Review Period, the second sentence of the third paragraph is corrected 
to read: ``FDA

[[Page 80318]]

has verified the applicant's claims that the new drug application (NDA) 
for ROZLYTREK CAPSULES (NDA 212726) was initially submitted on December 
18, 2018.''

    Dated: November 14, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-25489 Filed 11-16-23; 8:45 am]
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