Helsinn Healthcare SA; Withdrawal of Approval of New Drug Application for TRUSELTIQ (Infigratinib Phosphate) Capsules, 25 Milligrams and 100 Milligrams, 42887-42888 [2024-10714]
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Federal Register / Vol. 89, No. 96 / Thursday, May 16, 2024 / Notices
• SEKISUI Diagnostics, LLC’s OSOM
Flu SARS–CoV–2 Combo Test, issued
on February 29, 2024.5
• CorDx, Inc.’s, CorDx Tyfast Flu A/
B & COVID–19 Multiplex Rapid Test,
issued on March 21, 2024; 6
• OSANG LLC’s OHC COVID–19/Flu
Antigen Test Pro, issued on March 21,
2024.7
• OSANG LLC’s QuickFinder
COVID–19/Flu Antigen Self Test, issued
on April 3, 2024.8
• CorDx, Inc.’s CorDx TyFast Flu A/
B & COVID–19 At Home Multiplex
Rapid Test, issued on April 5, 2024; 9
and
• Wondfo USA Co., Ltd.’s WELLlife
COVID–19/Influenza A&B Test, issued
on April 19, 2024. 10
Dated: May 13, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–10717 Filed 5–15–24; 8:45 am]
BILLING CODE 4164–01–P
Food and Drug Administration
ddrumheller on DSK120RN23PROD with NOTICES1
5 As
set forth in the EUA for this product, FDA
has concluded that: (1) SARS–CoV–2 can cause a
serious or life-threatening disease or condition,
including severe respiratory illness, to humans
infected by this virus; (2) based on the totality of
scientific evidence available to FDA, it is reasonable
to believe that the product may be effective in
diagnosing COVID–19 through the simultaneous
detection and differentiation of SARS–CoV–2,
influenza A virus and/or influenza B virus protein
antigens, and that the known and potential benefits
of the product when used for diagnosing COVID–
19, outweigh the known and potential risks of such
product; and (3) there is no adequate, approved,
and available alternative to the emergency use of
the product.
6 As set forth in the EUA for this product, FDA
has concluded that: (1) SARS–CoV–2 can cause a
serious or life-threatening disease or condition,
including severe respiratory illness, to humans
infected by this virus; (2) based on the totality of
scientific evidence available to FDA, it is reasonable
to believe that the product may be effective in
diagnosing COVID–19 through the simultaneous
detection and differentiation of SARS–CoV–2,
influenza A virus and/or influenza B virus protein
antigens, and that the known and potential benefits
of the product when used for diagnosing COVID–
19, outweigh the known and potential risks of such
product; and (3) there is no adequate, approved,
and available alternative to the emergency use of
the product.
7 As set forth in the EUA for this product, FDA
has concluded that: (1) SARS–CoV–2 can cause a
serious or life-threatening disease or condition,
including severe respiratory illness, to humans
infected by this virus; (2) based on the totality of
scientific evidence available to FDA, it is reasonable
to believe that the product may be effective in
diagnosing COVID–19 through the simultaneous
detection and differentiation of SARS–CoV–2,
influenza A virus and/or influenza B virus protein
antigens, and that the known and potential benefits
of the product when used for diagnosing COVID–
19, outweigh the known and potential risks of such
product; and (3) there is no adequate, approved,
and available alternative to the emergency use of
the product.
8 As set forth in the EUA for this product, FDA
has concluded that: (1) SARS–CoV–2 can cause a
serious or life-threatening disease or condition,
including severe respiratory illness, to humans
infected by this virus; (2) based on the totality of
scientific evidence available to FDA, it is reasonable
to believe that the product may be effective in
diagnosing COVID–19 through the simultaneous
detection and differentiation of SARS–CoV–2,
influenza A virus and/or influenza B virus protein
antigens, and that the known and potential benefits
of the product when used for diagnosing COVID–
19, outweigh the known and potential risks of such
product; and (3) there is no adequate, approved,
and available alternative to the emergency use of
the product.
VerDate Sep<11>2014
17:50 May 15, 2024
Jkt 262001
Approval is withdrawn as of
May 16, 2024.
DATES:
FOR FURTHER INFORMATION CONTACT:
Kimberly Lehrfeld, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6226,
Silver Spring, MD 20993–0002, 301–
796–3137, Kimberly.Lehrfeld@
fda.hhs.gov.
On May
28, 2021, FDA approved NDA 214622
for TRUSELTIQ (infigratinib phosphate)
Capsules, 25 mg and 100 mg, for the
treatment of adults with previously
treated, unresectable locally advanced
or metastatic cholangiocarcinoma
(advanced bile duct cancer or advanced
cholangiocarcinoma) with a fibroblast
growth factor receptor 2 fusion or other
rearrangement as detected by an FDAapproved test, under the Agency’s
accelerated approval regulations, 21
CFR part 314, subpart H. The
accelerated approval of TRUSELTIQ
(infigratinib phosphate) Capsules, 25 mg
and 100 mg, for advanced bile duct
cancer or advanced cholangiocarcinoma
included required postmarketing trials
intended to verify the clinical benefit of
TRUSELTIQ.
On October 5, 2022, Helsinn
voluntarily requested withdrawal of
approval of TRUSELTIQ (infigratinib
phosphate) Capsules, 25 mg and 100
mg. On February 15, 2023, FDA
recommended that the applicant submit
a letter to voluntarily request
withdrawal of approval of TRUSELTIQ
(infigratinib phosphate) Capsules, 25 mg
and 100 mg, according to § 314.150(d)
(21 CFR 314.150(d)) due to the
company’s inability to conduct a
clinical trial to verify clinical benefit.
On April 21, 2023, FDA requested
Helsinn waive its opportunity for a
hearing.
On May 30, 2023, Helsinn submitted
a letter asking FDA to withdraw
approval of NDA 214622 for
TRUSELTIQ (infigratinib phosphate)
Capsules, 25 mg and 100 mg, according
to § 314.150(d) and waiving its
opportunity for a hearing. In its letter
requesting withdrawal of approval,
Helsinn stated that it is voluntarily
requesting withdrawal due to
difficulties in recruiting and enrolling
study subjects for the required
confirmatory clinical trial in first line
cholangiocarcinoma (a new indication
under investigation for TRUSELTIQ),
and the determination that, as a result,
continued distribution of TRUSELTIQ
in second line cholangiocarcinoma (the
accelerated approval indication) is not
commercially reasonable. Helsinn stated
SUPPLEMENTARY INFORMATION:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. FDA–2024–N–2178]
Helsinn Healthcare SA; Withdrawal of
Approval of New Drug Application for
TRUSELTIQ (Infigratinib Phosphate)
Capsules, 25 Milligrams and 100
Milligrams
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
withdrawing approval of the new drug
application (NDA) for TRUSELTIQ
(infigratinib phosphate) Capsules, 25
milligrams (mg) and 100 mg, held by
Helsinn Healthcare SA, C/O Helsinn
Therapeutics (U.S.), Inc. (Helsinn), 200
Wood Ave. South, Suite 100, Iselin, NJ
08830. Helsinn has voluntarily
requested that FDA withdraw approval
of this application and has waived its
opportunity for a hearing.
SUMMARY:
9 As set forth in the EUA for this product, FDA
has concluded that: (1) SARS–CoV–2 can cause a
serious or life-threatening disease or condition,
including severe respiratory illness, to humans
infected by this virus; (2) based on the totality of
scientific evidence available to FDA, it is reasonable
to believe that the product may be effective in
diagnosing COVID–19 through the simultaneous
detection and differentiation of SARS–CoV–2,
influenza A virus and/or influenza B virus protein
antigens, and that the known and potential benefits
of the product when used for diagnosing COVID–
19, outweigh the known and potential risks of such
product; and (3) there is no adequate, approved,
and available alternative to the emergency use of
the product.
10 As set forth in the EUA for this product, FDA
has concluded that: (1) SARS–CoV–2 can cause a
serious or life-threatening disease or condition,
including severe respiratory illness, to humans
infected by this virus; (2) based on the totality of
scientific evidence available to FDA, it is reasonable
to believe that the product may be effective in
diagnosing COVID–19 through the simultaneous
detection and differentiation of SARS–CoV–2,
influenza A virus and/or influenza B virus protein
antigens, and that the known and potential benefits
of the product when used for diagnosing COVID–
19, outweigh the known and potential risks of such
product; and (3) there is no adequate, approved,
and available alternative to the emergency use of
the product.
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Federal Register / Vol. 89, No. 96 / Thursday, May 16, 2024 / Notices
that it agreed to withdrawal of the
application for this reason only.
For the reasons discussed above, and
in accordance with the applicant’s
request, approval of NDA 214622 for
TRUSELTIQ (infigratinib phosphate)
Capsules, 25 mg and 100 mg, and all
amendments and supplements thereto,
is withdrawn under § 314.150(d).
Distribution of TRUSELTIQ (infigratinib
phosphate) Capsules, 25 mg and 100
mg, into interstate commerce without an
approved application is illegal and
subject to regulatory action (see sections
505(a) and 301(d) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C.
355(a) and 331(d))).
Dated: May 13, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–10714 Filed 5–15–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
sponsors of approved rare pediatric
disease product applications that meet
certain criteria. FDA has determined
that XOLREMDI (mavorixafor),
manufactured by X4 Pharmaceuticals,
Inc., meets the criteria for a priority
review voucher. XOLREMDI
(mavorixafor) is indicated for the
treatment of WHIM (warts,
hypogammaglobulinemia, infections,
and myelokathexis) syndrome in
patients 12 years of age and older to
increase the number of circulating
mature neutrophils and lymphocytes.
For further information about the Rare
Pediatric Disease Priority Review
Voucher Program and for a link to the
full text of section 529 of the FD&C Act,
go to https://www.fda.gov/ForIndustry/
DevelopingProductsforRareDiseases
Conditions/RarePediatricDiseasePriority
VoucherProgram/default.htm. For
further information about XOLREMDI
(mavorixafor), go to the ‘‘Drugs@FDA’’
website at https://www.accessdata.
fda.gov/scripts/cder/daf/.
Dated: May 13, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
Food and Drug Administration
[Docket No. FDA–2020–N–0026]
[FR Doc. 2024–10715 Filed 5–15–24; 8:45 am]
Issuance of Priority Review Voucher;
Rare Pediatric Disease Product;
XOLREMDI (mavorixafor)
AGENCY:
BILLING CODE 4164–01–P
Food and Drug Administration,
HHS.
ACTION:
Notice.
National Institutes of Health
The Food and Drug
Administration (FDA) is announcing the
issuance of a priority review voucher to
the sponsor of a rare pediatric disease
product application. The Federal Food,
Drug, and Cosmetic Act (FD&C Act)
authorizes FDA to award priority review
vouchers to sponsors of approved rare
pediatric disease product applications
that meet certain criteria. FDA is
required to publish notice of the award
of the priority review voucher. FDA has
determined that XOLREMDI
(mavorixafor), approved on April 26,
2024, manufactured by X4
Pharmaceuticals, Inc., meets the criteria
for a priority review voucher.
FOR FURTHER INFORMATION CONTACT:
Cathryn Lee, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993–0002,
301–796–1394.
SUPPLEMENTARY INFORMATION: FDA is
announcing the issuance of a priority
review voucher to the sponsor of an
approved rare pediatric disease product
application. Under section 529 of the
FD&C Act (21 U.S.C. 360ff), FDA will
award priority review vouchers to
ddrumheller on DSK120RN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
17:50 May 15, 2024
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Jkt 262001
Center for Scientific Review; Notice of
Closed Meetings
Pursuant to section 1009 of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Population Sciences
and Epidemiology Integrated Review Group;
Social Sciences and Population Studies A
Study Section.
Date: June 6–7, 2024.
Time: 10:00 a.m. to 6:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892.
PO 00000
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Meeting Format: In Person and Virtual
Meeting.
Contact Person: Suzanne Ryan, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3139,
MSC 7770, Bethesda, MD 20892, (301) 435–
1712, ryansj@csr.nih.gov.
Name of Committee: Biobehavioral and
Behavioral Processes Integrated Review
Group; Child Psychopathology and
Developmental Disabilities Study Section.
Date: June 10–11, 2024.
Time: 9:00 a.m. to 8:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Aruna K Behera, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4211,
MSC 7814, Bethesda, MD 20892, (301) 435–
6809, beheraak@csr.nih.gov.
Name of Committee: Bioengineering
Sciences & Technologies Integrated Review
Group; Instrumentation and Systems
Development Study Section.
Date: June 11–12, 2024.
Time: 8:00 a.m. to 7:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: The Bethesdan Hotel, 8120
Wisconsin Avenue, Bethesda, MD 20814 (In
Person).
Contact Person: Zachary Stephen Bailey,
Ph.D., Scientific Review Officer, The Center
for Scientific Review, The National Institutes
of Health, 6701 Rockledge Drive, Bethesda,
MD 20892, (301) 594–4691, zach.bailey@
nih.gov.
Name of Committee: Integrative,
Functional and Cognitive Neuroscience
Integrated Review Group; Neurobiology of
Pain and Itch Study Section.
Date: June 11–12, 2024.
Time: 8:00 a.m. to 8:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (In Person and Virtual
Meeting).
Contact Person: Anne-Sophie Marie Lucie
Wattiez, Ph.D., Scientific Review Officer,
Center for Scientific Review, National
Institutes of Health, 6701 Rockledge Drive,
Bethesda, MD 20892, (301) 594–4642, annesophie.wattiez@nih.gov.
Name of Committee: Vascular and
Hematology Integrated Review Group;
Hemostasis, Thrombosis, Blood Cells and
Transfusion Study Section.
Date: June 11–12, 2024.
Time: 8:00 a.m. to 9:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: The Bethesdan Hotel, 8120
Wisconsin Avenue, Bethesda, MD 20814 (In
Person).
Contact Person: Vivian Tang, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Bethesda, MD
20892, (301) 594–6208, tangvw@csr.nih.gov.
E:\FR\FM\16MYN1.SGM
16MYN1
]]>Agencies
[Federal Register Volume 89, Number 96 (Thursday, May 16, 2024)]
[Notices]
[Pages 42887-42888]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-10714]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-2178]
Helsinn Healthcare SA; Withdrawal of Approval of New Drug
Application for TRUSELTIQ (Infigratinib Phosphate) Capsules, 25
Milligrams and 100 Milligrams
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is
withdrawing approval of the new drug application (NDA) for TRUSELTIQ
(infigratinib phosphate) Capsules, 25 milligrams (mg) and 100 mg, held
by Helsinn Healthcare SA, C/O Helsinn Therapeutics (U.S.), Inc.
(Helsinn), 200 Wood Ave. South, Suite 100, Iselin, NJ 08830. Helsinn
has voluntarily requested that FDA withdraw approval of this
application and has waived its opportunity for a hearing.
DATES: Approval is withdrawn as of May 16, 2024.
FOR FURTHER INFORMATION CONTACT: Kimberly Lehrfeld, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6226, Silver Spring, MD 20993-0002, 301-
796-3137, [email protected].
SUPPLEMENTARY INFORMATION: On May 28, 2021, FDA approved NDA 214622 for
TRUSELTIQ (infigratinib phosphate) Capsules, 25 mg and 100 mg, for the
treatment of adults with previously treated, unresectable locally
advanced or metastatic cholangiocarcinoma (advanced bile duct cancer or
advanced cholangiocarcinoma) with a fibroblast growth factor receptor 2
fusion or other rearrangement as detected by an FDA-approved test,
under the Agency's accelerated approval regulations, 21 CFR part 314,
subpart H. The accelerated approval of TRUSELTIQ (infigratinib
phosphate) Capsules, 25 mg and 100 mg, for advanced bile duct cancer or
advanced cholangiocarcinoma included required postmarketing trials
intended to verify the clinical benefit of TRUSELTIQ.
On October 5, 2022, Helsinn voluntarily requested withdrawal of
approval of TRUSELTIQ (infigratinib phosphate) Capsules, 25 mg and 100
mg. On February 15, 2023, FDA recommended that the applicant submit a
letter to voluntarily request withdrawal of approval of TRUSELTIQ
(infigratinib phosphate) Capsules, 25 mg and 100 mg, according to Sec.
314.150(d) (21 CFR 314.150(d)) due to the company's inability to
conduct a clinical trial to verify clinical benefit. On April 21, 2023,
FDA requested Helsinn waive its opportunity for a hearing.
On May 30, 2023, Helsinn submitted a letter asking FDA to withdraw
approval of NDA 214622 for TRUSELTIQ (infigratinib phosphate) Capsules,
25 mg and 100 mg, according to Sec. 314.150(d) and waiving its
opportunity for a hearing. In its letter requesting withdrawal of
approval, Helsinn stated that it is voluntarily requesting withdrawal
due to difficulties in recruiting and enrolling study subjects for the
required confirmatory clinical trial in first line cholangiocarcinoma
(a new indication under investigation for TRUSELTIQ), and the
determination that, as a result, continued distribution of TRUSELTIQ in
second line cholangiocarcinoma (the accelerated approval indication) is
not commercially reasonable. Helsinn stated
[[Page 42888]]
that it agreed to withdrawal of the application for this reason only.
For the reasons discussed above, and in accordance with the
applicant's request, approval of NDA 214622 for TRUSELTIQ (infigratinib
phosphate) Capsules, 25 mg and 100 mg, and all amendments and
supplements thereto, is withdrawn under Sec. 314.150(d). Distribution
of TRUSELTIQ (infigratinib phosphate) Capsules, 25 mg and 100 mg, into
interstate commerce without an approved application is illegal and
subject to regulatory action (see sections 505(a) and 301(d) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(a) and 331(d))).
Dated: May 13, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-10714 Filed 5-15-24; 8:45 am]
BILLING CODE 4164-01-P
