Notice2025-18813
Determination That SEMPREX-D (Acrivastine and Pseudoephedrine Hydrochloride) Capsules, 8 Milligrams and 60 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
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
September 29, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) has determined that SEMPREX-D (acrivastine and pseudoephedrine hydrochloride) capsules, 8 milligrams (mg) and 60 mg, was not withdrawn from sale for reasons of safety or effectiveness.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 acrivastine and pseudoephedrine hydrochloride capsules, 8 mg and 60 mg, if all other legal and regulatory requirements are met.
Full Text
<html>
<head>
<title>Federal Register, Volume 90 Issue 186 (Monday, September 29, 2025)</title>
</head>
<body><pre>
[Federal Register Volume 90, Number 186 (Monday, September 29, 2025)]
[Notices]
[Pages 46605-46606]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-18813]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-P-1028]
Determination That SEMPREX-D (Acrivastine and Pseudoephedrine
Hydrochloride) Capsules, 8 Milligrams and 60 Milligrams, Was Not
Withdrawn From Sale for Reasons of Safety or Effectiveness
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) has
determined that SEMPREX-D (acrivastine and pseudoephedrine
hydrochloride) capsules, 8 milligrams (mg) and 60 mg, was not withdrawn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
acrivastine and pseudoephedrine hydrochloride capsules, 8 mg and 60 mg,
if all other legal and regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT: Stacy Kane, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, Rm. 6236, Silver Spring, MD 20993-0002, 301-796-8363,
<a href="/cdn-cgi/l/email-protection#0c5f786d6f7522476d62694c6a686d2264647f226b637a"><span class="__cf_email__" data-cfemail="c497b0a5a7bdea8fa5aaa184a2a0a5eaacacb7eaa3abb2">[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.
SEMPREX-D (acrivastine and pseudoephedrine hydrochloride) capsules,
8 mg and 60 mg, is the subject of NDA 019806, held by Endo
Pharmaceuticals, and initially approved on March 25, 1994. SEMPREX-D is
indicated for relief of symptoms associated with seasonal allergic
rhinitis such as sneezing, rhinorrhea, pruritus, lacrimation, and nasal
congestion.
In a letter dated August 3, 2020, Endo Pharmaceuticals notified FDA
that SEMPREX-D (acrivastine and pseudoephedrine hydrochloride)
capsules, 8 mg and 60 mg, 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
April 1, 2025 (Docket No. FDA-2025-P-1028), under 21 CFR 10.30,
requesting that the Agency determine whether SEMPREX-D (acrivastine and
pseudoephedrine hydrochloride) capsules, 8 mg and 60 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 SEMPREX-D (acrivastine and pseudoephedrine
hydrochloride) capsules, 8 mg and 60 mg, was not withdrawn for reasons
of safety or effectiveness. The petitioner has identified no data or
other information suggesting that SEMPREX-D (acrivastine and
pseudoephedrine hydrochloride) capsules, 8 mg and 60 mg, was withdrawn
for reasons of safety or effectiveness. We have carefully reviewed our
files for records concerning the withdrawal of SEMPREX-D (acrivastine
and pseudoephedrine hydrochloride) capsules, 8 mg and 60 mg, 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 SEMPREX-D
(acrivastine and pseudoephedrine hydrochloride) capsules, 8 mg and 60
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
SEMPREX-D (acrivastine and pseudoephedrine hydrochloride) capsules, 8
mg and 60 mg, 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
[[Page 46606]]
will advise ANDA applicants to submit such labeling.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-18813 Filed 9-26-25; 8:45 am]
BILLING CODE 4164-01-P
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on September 29, 2025.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.