Notice2026-19921
Determination That SULFADIAZINE (Sulfadiazine) Tablet, 500 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Primary source
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Published
September 29, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) has determined that SULFADIAZINE (sulfadiazine) tablet, 500 milligrams (mg), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for SULFADIAZINE (sulfadiazine) tablet, 500 mg, if all other legal and regulatory requirements are met.
Full Text
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<title>Federal Register, Volume 91 Issue 187 (Tuesday, September 29, 2026)</title>
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[Federal Register Volume 91, Number 187 (Tuesday, September 29, 2026)]
[Notices]
[Pages 61407-61408]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-19921]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-P-0394]
Determination That SULFADIAZINE (Sulfadiazine) Tablet, 500
Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or
Effectiveness
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA or Agency) has
determined that SULFADIAZINE (sulfadiazine) tablet, 500 milligrams
(mg), was not withdrawn from sale for reasons of safety or
effectiveness. This determination will allow FDA to approve abbreviated
new drug applications (ANDAs) for SULFADIAZINE (sulfadiazine) tablet,
500 mg, if all other legal and regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT: Madeleine Giaquinto, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6219, Silver Spring, MD 20993-0002, 240-
863-8976, <a href="/cdn-cgi/l/email-protection#e1ac8085848d84888f84cfa688809094888f958ea1878580cf898992cf868e97"><span class="__cf_email__" data-cfemail="206d4144454c45494e450e6749415155494e544f604644410e4848530e474f56">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: Section 505(j) of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)) allows the submission of
an ANDA to market a generic version of a previously approved drug
product. To obtain approval, the ANDA applicant must show, among other
things, that the generic drug product: (1) has the same active
ingredient(s), dosage form, route of administration, strength,
conditions of use, and (with certain exceptions) labeling as the listed
drug, which is a version of the drug that was previously approved, and
(2) is bioequivalent to the listed drug. ANDA applicants do not have to
repeat the extensive clinical testing otherwise necessary to gain
approval of a new drug application (NDA).
Section 505(j)(7) of the FD&C Act requires FDA to publish a list of
all approved drugs. FDA publishes this list as part of the ``Approved
Drug Products With Therapeutic Equivalence Evaluations,'' which is
known generally as the ``Orange Book.'' Under FDA regulations, drugs
are removed from the list if the Agency withdraws or suspends approval
of the drug's NDA or ANDA for reasons of safety or effectiveness or if
FDA determines that the listed drug was withdrawn from sale for reasons
of safety or effectiveness (21 CFR 314.162).
A person may petition the Agency to determine, or the Agency may
determine on its own initiative, whether a listed drug was withdrawn
from sale for reasons of safety or effectiveness. This determination
may be made at any time after the drug has been withdrawn from sale but
must be made prior to approving an ANDA that refers to the listed drug
(Sec. 314.161 (21 CFR 314.161)). FDA may not approve an ANDA that does
not refer to a listed drug.
SULFADIAZINE (sulfadiazine) tablet, 500 mg, is the subject of NDA
004122, held by Eli Lilly and Co., and initially approved on August 26,
1941. SULFADIAZINE is indicated for the treatment of infections as
specified in its labeling.
[[Page 61408]]
In a letter dated May 16, 1996, Lilly Research Laboratories
notified FDA that SULFADIAZINE (sulfadiazine) tablet, 500 mg, was being
discontinued, and FDA moved the drug product to the ``Discontinued Drug
Product List'' section of the Orange Book.
Rising Pharma Holdings, Inc. submitted a citizen petition dated
February 4, 2025 (Docket No. FDA-2025-P-0394), under 21 CFR 10.30,
requesting that the Agency determine whether SULFADIAZINE
(sulfadiazine) tablet, 500 mg, was withdrawn from sale for reasons of
safety or effectiveness.
After considering the citizen petition and reviewing Agency records
and based on the information we have at this time, FDA has determined
under Sec. 314.161 that SULFADIAZINE (sulfadiazine) tablet, 500 mg,
was not withdrawn for reasons of safety or effectiveness. The
petitioner has identified no data or other information suggesting that
this drug product was withdrawn for reasons of safety or effectiveness.
We have carefully reviewed our files for records concerning the
withdrawal of SULFADIAZINE (sulfadiazine) tablet, 500 mg, from sale. We
have also independently evaluated relevant literature and data for
possible postmarketing adverse events. We have reviewed the available
evidence and determined that this drug product was not withdrawn from
sale for reasons of safety or effectiveness.
Accordingly, the Agency will continue to list SULFADIAZINE
(sulfadiazine) tablet, 500 mg, in the ``Discontinued Drug Product
List'' section of the Orange Book. The ``Discontinued Drug Product
List'' delineates, among other items, drug products that have been
discontinued from marketing for reasons other than safety or
effectiveness. ANDAs that refer to this drug product may be approved by
the Agency as long as they meet all other legal and regulatory
requirements for the approval of ANDAs. If FDA determines that labeling
for this drug product should be revised to meet current standards, the
Agency will advise ANDA applicants to submit such labeling.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-19921 Filed 9-28-26; 8:45 am]
BILLING CODE 4164-01-P
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