[Federal Register Volume 90, Number 151 (Friday, August 8, 2025)]
[Notices]
[Pages 38473-38474]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-15082]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2007-D-0369]
Product-Specific Guidance on Iron Sucrose; Draft Guidance for
Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing the availability of a revised draft guidance for industry
entitled ``Draft Guidance on Iron Sucrose.'' This revised draft
guidance, when finalized, will provide product-specific recommendations
on, among other things, the design of bioequivalence (BE) studies to
support abbreviated new drug applications (ANDAs) for iron sucrose
intravenous injectable.
DATES: Submit either electronic or written comments on the draft
guidance by October 7, 2025 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.
ADDRESSES: You may submit comments on any guidance at any time as
follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2007-D-0369 for ``Draft Guidance on Iron Sucrose.'' Received
comments will be placed in the docket and, except for those submitted
as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the
[[Page 38474]]
heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one
self-addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT: Joseph Kotsybar, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 3623A, Silver Spring, MD 20993-0002, 240-
402-1062, [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of June 11, 2010 (75 FR 33311), FDA
announced the availability of a guidance for industry entitled
``Bioequivalence Recommendations for Specific Products'' that explained
the process that would be used to make product-specific guidances
available to the public on FDA's website at https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs.
As described in that guidance, FDA adopted this process as a means
to develop and disseminate product-specific guidances and provide a
meaningful opportunity for the public to consider and comment on those
guidances. This notice announces the availability of a revised draft
product-specific guidance on generic iron sucrose intravenous
injectable.
FDA initially approved new drug application (NDA) 021135 VENOFER
(iron sucrose intravenous injectable) in November 2000 and NDA 205109
VELPHORO (sucroferric oxyhydroxide oral tablet) in November 2013.\1\ In
April 2016, Foley & Hoag LLP, on behalf of Vifor Fresenius Medical Care
Renal Pharma France, holder of NDA 205109 VELPHORO, submitted a citizen
petition requesting, among other things, that FDA grant five-year new
chemical entity exclusivity pursuant to sections 505(j)(5)(F)(ii) and
505(c)(3)(E)(ii) of the Federal Food, Drug, and Cosmetic Act to
VELPHORO and stay the acceptance, receipt, filing, review, and/or
approval of any ANDAs or 505(b)(2) applications referencing VELPHORO
while FDA considers VELPHORO's new chemical entity exclusivity (Docket
No. FDA-2016-P-1163, available at https://www.regulations.gov). On May
26, 2021, FDA issued a response to that citizen petition noting that
the active ingredient of multiple iron products, including VELPHORO and
VENOFER, is ferric oxyhydroxide.2 3
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\1\ The active ingredients were identified as iron sucrose and
sucroferric oxyhydroxide, respectively, at the time of approval of
these NDAs.
\2\ See Letter to Areta Kupchyk, Foley Hoag LLP, from Patrizia
Cavazzoni, M.D., Acting Director, Center for Drug Evaluation and
Research, Docket No. FDA-2016-P-1163 (May 26, 2021).
\3\ In March 2005, Sonnenschein, Nath & Rosenthal LLP submitted
a citizen petition requesting, among other things, that FDA withhold
approval of any ANDA or section 505(b)(2) application that
references VENOFER unless certain conditions are satisfied,
including conditions related to demonstrating BE. (Docket No. FDA-
2005-P-0319). The issues raised by that petition are under review by
the Agency, and FDA has not made a final decision on those issues.
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In August 2021, Sidley Austin LLP, on behalf of Vifor
(International) Inc., Switzerland (Vifor),\4\ submitted a citizen
petition requesting that FDA refrain from taking several actions,
including changing the product label or labeling for VENOFER, modifying
the existing product-specific guidance for VENOFER, and/or changing the
established name of VENOFER from iron sucrose to ferric oxyhydroxide
(Docket No. FDA-2021-P-0893, available https://www.regulations.gov). In
September 2021, FDA issued a revised draft product-specific guidance
for industry on generic ferric oxyhydroxide intravenous injectable and
stated that FDA is reviewing the issues raised in the petition and will
consider any comments on the draft guidance before responding to the
petition.\5\ In July 2024, FDA issued a memo to the Docket No. FDA-
2021-P-0893 stating that FDA is reevaluating its determination that the
active ingredient of the iron products subject to the May 26, 2021
citizen petition response is ferric oxyhydroxide. We are now issuing a
revised draft guidance for industry on generic iron sucrose intravenous
injectable. FDA is separately responding to Vifor's citizen petition
(FDA-2021-P-0893).
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\4\ Vifor (International) Inc., Switzerland is a Swiss
pharmaceutical company, which is the drug master file holder for
iron sucrose and the owner of the VENOFER trademark and logo. Vifor
licenses VENOFER in the United States to American Regent, Inc., the
holder of the NDA for VENOFER. The NDA holder for VELPHORO is Vifor
Fresenius Medical Care Renal Pharma France, which is a joint venture
established by Vifor's parent company and Fresenius Medical Care.
\5\ 86 FR 51898 (September 17, 2021).
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This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on ``Draft
Guidance on Iron Sucrose.'' It does not establish any rights for any
person and is not binding on FDA or the public. You can use an
alternative approach if it satisfies the requirements of the applicable
statutes and regulations.
As we develop final guidance on this topic, FDA will consider
comments on costs or cost savings the guidance may generate, relevant
for Executive Order 14192.
II. Paperwork Reduction Act of 1995
While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. The
previously approved collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501-3521). The collections of information in 21
CFR part 312 for investigational new drugs have been approved under OMB
control number 0910-0014. The collections of information in 21 CFR part
314 for applications for FDA approval to market a new drug and in 21
CFR part 320 for bioavailability and bioequivalence requirements have
been approved under OMB control number 0910-0001.
III. Electronic Access
Persons with access to the internet may obtain the draft guidance
at https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.
Dated: August 1, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-15082 Filed 8-7-25; 8:45 am]
BILLING CODE 4164-01-P