[Federal Register Volume 78, Number 213 (Monday, November 4, 2013)]
[Notices]
[Pages 66009-66010]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-26283]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-P-0775]


Determination That INVEGA (Paliperidone) Extended-Release Tablet, 
12 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or 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) has determined that 
INVEGA (paliperidone) extended-release tablet, 12 milligrams (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not withdrawn from sale for reasons of safety or effectiveness.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 paliperidone extended-release tablet, 12 mg, 
if all other legal and regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT: Linda Jong, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 51, Rm. 6224, Silver Spring, MD 20993-0002, 301-796-3977.

SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price 
Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) 
(the 1984 amendments), which authorized the approval of duplicate 
versions of drug products under an ANDA procedure. ANDA applicants 
must, with certain exceptions, show that the drug for which they are 
seeking approval contains the same active ingredient in the same 
strength and dosage form as the ``listed drug,'' which is a version of 
the drug that was previously approved. ANDA applicants do not have to 
repeat the extensive clinical testing otherwise necessary to gain 
approval of a new drug application (NDA).
    The 1984 amendments include what is now section 505(j)(7) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which 
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drug was withdrawn from sale for reasons of safety or effectiveness (21 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, 12 mg, is the 
subject of NDA 21-999, held by Janssen Pharmaceuticals, Inc., and 
initially approved on December 19, 2006. INVEGA extended-release 
tablets are indicated for the treatment of schizophrenia and the 
treatment of schizoaffective disorder as monotherapy and as an adjunct 
to mood stabilizers and/or antidepressants.
    Janssen Pharmaceuticals, Inc., has never marketed INVEGA 
(paliperidone) extended-release tablet, 12 mg. In previous instances 
(see, e.g., 72 FR 9763, 61 FR 25497), the Agency has determined that, 
for purposes of Sec. Sec.  314.161 and 314.162, never marketing an 
approved drug product is equivalent to withdrawing the drug from sale. 
The other strengths of INVEGA (paliperidone) that are approved under 
NDA 21-999 are being marketed.
    Hyman, Phelps & McNamara, P.C., submitted a citizen petition dated 
June 25, 2013 (Docket No. FDA-2013-P-0775), under 21 CFR 10.30, 
requesting that the Agency determine whether

[[Page 66010]]

INVEGA (paliperidone) extended-release tablet, 12 mg, was discontinued 
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, 
12 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, 12 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, 12 mg, from sale. We have also independently 
evaluated relevant literature and data for possible postmarketing 
adverse events to determine whether INVEGA (paliperidone) extended-
release tablet, 12 mg, was withdrawn for reasons of safety or 
effectiveness. We have reviewed the available information and 
determined that the product was not withdrawn from sale for reasons of 
safety or effectiveness.
    Accordingly, the Agency will continue to list INVEGA (paliperidone) 
extended-release tablet, 12 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 INVEGA (paliperidone) extended-
release tablet, 12 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: October 29, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-26283 Filed 11-1-13; 8:45 am]
BILLING CODE 4160-01-P