Notice2025-14707
Determination That ROXICET (Oxycodone Hydrochloride and Acetaminophen) Tablet, 5 Milligrams and 325 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness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
August 4, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) has determined that ROXICET (oxycodone hydrochloride (HCl) and acetaminophen) tablet, 5 milligrams (mg)/325 mg, was not withdrawn from sale for reasons of safety or effectiveness.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 oxycodone HCl and acetaminophen tablet, 5 mg/ 325 mg, if all other legal and regulatory requirements are met.
Full Text
<html>
<head>
<title>Federal Register, Volume 90 Issue 147 (Monday, August 4, 2025)</title>
</head>
<body><pre>
[Federal Register Volume 90, Number 147 (Monday, August 4, 2025)]
[Notices]
[Pages 36441-36442]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-14707]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-P-0410]
Determination That ROXICET (Oxycodone Hydrochloride and
Acetaminophen) Tablet, 5 Milligrams and 325 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Withdrawn From Sale for Reasons of Safety or Effectiveness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 ROXICET (oxycodone
[[Page 36442]]
hydrochloride (HCl) and acetaminophen) tablet, 5 milligrams (mg)/325
mg, was not withdrawn from sale for reasons of safety or effectiveness.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 oxycodone HCl and acetaminophen tablet, 5 mg/
325 mg, if all other legal and regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT: Alexander Poonai, J.D., Center for
Drug Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6213, Silver Spring, MD 20993-0002, 301-
796-3600, <a href="/cdn-cgi/l/email-protection#2d4c4148554c4349485f035d4242434c446d4b494c0345455e034a425b"><span class="__cf_email__" data-cfemail="5c3d3039243d3238392e722c3333323d351c3a383d7234342f723b332a">[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 (21 CFR 314.161). FDA may not approve an ANDA that does not refer
to a listed drug.
ROXICET (oxycodone HCl and acetaminophen) tablet, 5 mg/325 mg, is
the subject of ANDA 087003, held by Hikma Pharmaceuticals USA Inc., and
initially approved on February 25, 1980. ROXICET is indicated for the
relief of moderate to moderately severe pain.
ROXICET (oxycodone HCl and acetaminophen) tablet, 5 mg/325 mg, is
currently listed in the ``Discontinued Drug Product List'' section of
the Orange Book.
Nostrum Laboratories, Inc. submitted a citizen petition dated
February 5, 2025 (Docket No. FDA-2025-P-0410), under 21 CFR 10.30,
requesting that the Agency determine whether ROXICET (oxycodone HCl and
acetaminophen) tablet, 5 mg/325 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 ROXICET (oxycodone HCl and acetaminophen)
tablet, 5 mg/325 mg, was not withdrawn for reasons of safety or
effectiveness. The petitioner has identified no data or other
information suggesting that ROXICET (oxycodone HCl and acetaminophen)
tablet, 5 mg/325 mg, was withdrawn for reasons of safety or
effectiveness. We have carefully reviewed our files for records
concerning the withdrawal of ROXICET (oxycodone HCl and acetaminophen)
tablet, 5 mg/325 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 ROXICET (oxycodone
HCl and acetaminophen) tablet, 5 mg/325 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 ROXICET (oxycodone HCl and
acetaminophen) tablet, 5 mg/325 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 will
advise ANDA applicants to submit such labeling.
Dated: July 29, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-14707 Filed 8-1-25; 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 August 4, 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.