[Federal Register Volume 88, Number 34 (Tuesday, February 21, 2023)]
[Notices]
[Pages 10522-10523]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-03516]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-P-1939]


Determination That TOPAMAX (Topiramate) Sprinkle 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Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or 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, Agency, or we) has 
determined that TOPAMAX (topiramate) sprinkle capsules, 50 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(mg), was not withdrawn from sale for reasons of safety or 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 topiramate, sprinkle capsules, 50 mg, 
if all other legal and regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT: Alexandria Fujisaki, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6222,

[[Page 10523]]

Silver Spring, MD 20993-0002, 240-402-4078, 
[email protected].

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FDA determines that the listed drug was withdrawn from sale for reasons 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 (Sec.  314.162 (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.
    TOPAMAX (topiramate) sprinkle capsules, 50 mg, is the subject of 
NDA 020844, held by Janssen Pharmaceuticals, Inc., and initially 
approved on October 26, 1998. TOPAMAX is indicated for epilepsy 
(initial monotherapy for the treatment of partial-onset or primary 
generalized tonic-clonic seizures in patients 2 years of age and older; 
adjunctive therapy for the treatment of partial-onset seizures, primary 
generalized tonic-clonic seizures, or seizures associated with Lennox-
Gastaut syndrome in patients 2 years of age and older) and preventive 
treatment of migraine in patients 12 years of age and older.
    Janssen Pharmaceuticals, Inc., has never marketed TOPAMAX 
(topiramate) sprinkle capsules, 50 mg. In previous instances (see, 
e.g., 72 FR 9763, March 5, 2007; 61 FR 25497, May 21, 1996), 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.
    Hyman, Phelps & McNamara, P.C. submitted a citizen petition dated 
August 17, 2022 (Docket No. FDA-2022-P-1939), under 21 CFR 10.30, 
requesting that the Agency determine whether TOPAMAX (topiramate) 
sprinkle 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 TOPAMAX (topiramate) sprinkle capsules, 50 mg, 
was not withdrawn for reasons of safety or effectiveness. The 
petitioner has identified no data or other information suggesting that 
TOPAMAX (topiramate) sprinkle capsules, 50 mg, was withdrawn for 
reasons of safety or effectiveness. We have carefully reviewed our 
files for records concerning the withdrawal of TOPAMAX (topiramate) 
sprinkle 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 TOPAMAX (topiramate) 
sprinkle 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. ANDAs that refer to TOPAMAX (topiramate) sprinkle 
capsules, 50 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: February 15, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-03516 Filed 2-17-23; 8:45 am]
BILLING CODE 4164-01-P