[Federal Register Volume 84, Number 163 (Thursday, August 22, 2019)]
[Notices]
[Pages 43812-43813]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-18089]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-P-0076]


Determination That ZONEGRAN (Zonisamide) Capsules, 50 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Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness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 or Agency) has 
determined that ZONEGRAN (zonisamide) capsules, 50 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not withdrawn from sale for reasons of safety or effectiveness.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: Daniel Gottlieb, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6210, Silver Spring, MD 20993-0002, 301-
796-6650, Daniel.Gottlieb@fda.hhs.gov.

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

[[Page 43813]]

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.
    ZONEGRAN (zonisamide) capsules, 50 mg, is the subject of NDA 
020789, held by Sunovion Pharmaceuticals Inc., and initially approved 
on August 22, 2003. ZONEGRAN (zonisamide) is indicated as adjunctive 
therapy in the treatment of partial seizures in adults with epilepsy. 
ZONEGRAN (zonisamide) capsules, 50 mg, is currently listed in the 
``Discontinued Drug Product List'' section of the Orange Book.
    Unichem Pharmaceuticals (USA), Inc., submitted a citizen petition 
dated December 28, 2018 (Docket No. FDA-2019-P-0076), under 21 CFR 
10.30, requesting that the Agency determine whether ZONEGRAN 
(zonisamide) capsules, 50 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 ZONEGRAN (zonisamide) capsules, 50 mg, was not 
withdrawn for reasons of safety or effectiveness. The petitioner has 
identified no data or other information suggesting that this drug 
product was withdrawn for reasons of safety or effectiveness. We have 
carefully reviewed our files for records concerning the withdrawal of 
ZONEGRAN (zonisamide) capsules, 50 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 ZONEGRAN (zonisamide) 
capsules, 50 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: August 16, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-18089 Filed 8-21-19; 8:45 am]
 BILLING CODE 4164-01-P


