4164-01-P
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Was not Withdrawn from Sale for Reasons of Safety or Effectiveness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.
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INVEGA (paliperidone) extended-release tablet, 1.5 milligrams (mg), was not withdrawn from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, Stacy.Kane@fda.hhs.gov.
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withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162).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initiative, whether a listed drug was withdrawn from sale for reasons of safety or effectiveness.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 (§ 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 § 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: 6/21/2024 8:45 am; Publication Date: 6/24/2024]