[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Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or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(mg), was not withdrawn from sale for reasons of safety or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FDA determines that the listed drug was withdrawn from sale for reasons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