Notice2024-10714
Helsinn Healthcare SA; Withdrawal of Approval of New Drug Application for TRUSELTIQ (Infigratinib Phosphate) Capsules, 25 Milligrams and 100 Milligrams
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
May 16, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 89 Issue 96 (Thursday, May 16, 2024)</title>
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[Federal Register Volume 89, Number 96 (Thursday, May 16, 2024)]
[Notices]
[Pages 42887-42888]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-10714]
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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.
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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DATES: Approval is withdrawn as of May 16, 2024.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, <a href="/cdn-cgi/l/email-protection#652e0c08070017091c4b29000d1703000901250301044b0d0d164b020a13"><span class="__cf_email__" data-cfemail="9ed5f7f3fcfbecf2e7b0d2fbf6ecf8fbf2fadef8faffb0f6f6edb0f9f1e8">[email protected]</span></a>.
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
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