Notice2025-23419
Determination That DEXCHLORPHENIRAMINE MALEATE (Dexchlorpheniramine Maleate, Oral Syrup, 2 Milligrams/5 Milliliters) Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Primary source
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Published
December 19, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, Agency, or we) has determined that DEXCHLORPHENIRAMINE MALEATE (dexchlorpheniramine maleate, oral syrup, 2 milligrams (mg)/5 milliliters (ml)), was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.
Full Text
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<title>Federal Register, Volume 90 Issue 242 (Friday, December 19, 2025)</title>
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[Federal Register Volume 90, Number 242 (Friday, December 19, 2025)]
[Notices]
[Pages 59530-59531]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-23419]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-P-1562]
Determination That DEXCHLORPHENIRAMINE MALEATE
(Dexchlorpheniramine Maleate, Oral Syrup, 2 Milligrams/5 Milliliters)
Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness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, Agency, or we) has
determined that DEXCHLORPHENIRAMINE MALEATE (dexchlorpheniramine
maleate, oral syrup, 2 milligrams (mg)/5 milliliters (ml)), was not
withdrawn from sale for reasons of safety or effectiveness. This
determination means that FDA will not begin procedures to withdraw
approval of abbreviated new drug applications (ANDAs) that refer to
this drug product, and it will allow FDA to continue to approve ANDAs
that refer to the product as long as they meet relevant legal and
regulatory requirements.
FOR FURTHER INFORMATION CONTACT: Molly Arndt, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6281, Silver Spring, MD 20993-0002, 240-
402-6919, <a href="/cdn-cgi/l/email-protection#a0edcfccccd98ee1d2cec4d4e0c6c4c18ec8c8d38ec7cfd6"><span class="__cf_email__" data-cfemail="034e6c6f6f7a2d42716d6777436567622d6b6b702d646c75">[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. DEXCHLORPHENIRAMINE MALEATE
(dexchlorpheniramine maleate, oral syrup, 2 mg/5 ml), is the subject of
ANDA 088251, held by PAI Holdings, LLC, and initially approved on March
23, 1984. DEXCHLORPHENIRAMINE MALEATE is indicated for
<bullet> Perennial and seasonal allergic rhinitis
<bullet> Vasomotor rhinitis
<bullet> Allergic conjunctivitis due to inhalant allergens and
foods
<bullet> Mild, uncomplicated allergic skin manifestations of
urticaria and angioedema
<bullet> Amelioration of allergic reactions to blood or plasma
<bullet> Dermographism
<bullet> As therapy for anaphylactic reactions adjunctive to
epinephrine and other standard measures after the acute manifestations
have been controlled
On March 8, 2024, PAI Holdings, LLC, notified FDA that
DEXCHLORPHENIRAMINE MALEATE (dexchlorpheniramine maleate, oral syrup, 2
mg/5 ml), was being discontinued, and FDA moved the drug product to the
``Discontinued Drug Product List'' section of the Orange Book.
Pharmobedient Consulting, LLC submitted a citizen petition dated
June 4, 2025 (Docket No. FDA-2025-P-1562), under 21 CFR 10.30,
requesting that the Agency determine whether DEXCHLORPHENIRAMINE
MALEATE (dexchlorpheniramine maleate, oral
[[Page 59531]]
syrup, 2 mg/5 ml), 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 DEXCHLORPHENIRAMINE MALEATE
(dexchlorpheniramine maleate, oral syrup, 2 mg/5 ml), was not withdrawn
for reasons of safety or effectiveness. The petitioner has identified
no data or other information suggesting that DEXCHLORPHENIRAMINE
MALEATE (dexchlorpheniramine maleate, oral syrup, 2 mg/5 ml), was
withdrawn for reasons of safety or effectiveness. We have carefully
reviewed our files for records concerning the withdrawal of
DEXCHLORPHENIRAMINE MALEATE (dexchlorpheniramine maleate, oral syrup, 2
mg/5 ml), from sale. We have also independently evaluated relevant
literature and data for possible postmarketing adverse events. We have
found no information that would indicate that this drug product was
withdrawn from sale for reasons of safety or effectiveness.
Accordingly, the Agency will continue to list DEXCHLORPHENIRAMINE
MALEATE (dexchlorpheniramine maleate, oral syrup, 2 mg/5 ml), 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. FDA will not begin procedures to withdraw
approval of approved ANDAs that refer to this drug product. Additional
ANDAs for this drug product may also 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.
Lowell M. Zeta,
Acting Deputy Commissioner for Policy, Legislation, and International
Affairs.
[FR Doc. 2025-23419 Filed 12-18-25; 8:45 am]
BILLING CODE 4164-01-P
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