Notice2024-13803
Determination That INVEGA (Paliperidone) Extended-Release Tablet, 1.5 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Primary source
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Published
June 24, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, Agency, or we) has determined that INVEGA (paliperidone) extended-release tablet, 1.5 milligrams (mg), was not withdrawn from sale for reasons of safety or effectiveness.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 89 Issue 121 (Monday, June 24, 2024)</title>
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[Federal Register Volume 89, Number 121 (Monday, June 24, 2024)]
[Notices]
[Page 52468]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-13803]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-P-2272]
Determination That INVEGA (Paliperidone) Extended-Release Tablet,
1.5 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or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, Agency, or we) has
determined that INVEGA (paliperidone) extended-release tablet, 1.5
milligrams (mg), was not withdrawn from sale for reasons of safety or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: 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#15466174766c3b5e747b70557371743b7d7d663b727a63"><span class="__cf_email__" data-cfemail="ce9dbaafadb7e085afa0ab8ea8aaafe0a6a6bde0a9a1b8">[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.
INVEGA (paliperidone) extended-release tablet, 1.5 mg, is the
subject of NDA 021999, held by Janssen Pharmaceuticals, Inc. NDA 021999
was initially approved on December 19, 2006, for the INVEGA
paliperidone extended-release 3 mg, 6 mg, 9 mg, and 12 mg dose tablets,
and the supplement for the INVEGA paliperidone extended-release 1.5 mg
dose tablet was approved on August 26, 2008. INVEGA is indicated for
the treatment of schizophrenia and schizoaffective disorder.
In a letter dated February 9, 2023, Janssen Pharmaceuticals, Inc.,
notified FDA that INVEGA (paliperidone) extended-release tablet, 1.5
mg, was being discontinued, and FDA moved the drug product to the
``Discontinued Drug Product List'' section of the Orange Book.
Aurobindo Pharma USA, Inc., submitted a citizen petition dated May
7, 2024 (Docket No. FDA-2024-P-2272), under 21 CFR 10.30, requesting
that the Agency determine whether INVEGA (paliperidone) extended-
release tablet, 1.5 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 INVEGA (paliperidone) extended-release tablet,
1.5 mg, was not withdrawn for reasons of safety or effectiveness. The
petitioner has identified no data or other information suggesting that
INVEGA (paliperidone) extended-release tablet, 1.5 mg, was withdrawn
for reasons of safety or effectiveness. We have carefully reviewed our
files for records concerning the withdrawal of INVEGA (paliperidone)
extended-release tablet, 1.5 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 INVEGA (paliperidone)
extended-release tablet, 1.5 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. 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.
Dated: June 18, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-13803 Filed 6-21-24; 8:45 am]
BILLING CODE 4164-01-P
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