[Federal Register Volume 78, Number 225 (Thursday, November 21, 2013)]
[Notices]
[Pages 69856-69857]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-27874]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-P-0573]
Determination That BANZEL (Rufinamide) Tablet, 100 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Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness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
BANZEL (rufinamide) tablet, 100 milligrams (mg), was not withdrawn from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
rufinamide tablet, 100 mg, if all other legal and regulatory
requirements are met.
FOR FURTHER INFORMATION CONTACT: Olivia Morris, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6260, Silver Spring, MD 20993-0002, 301-
796-3601.
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withdrawn from sale for reasons of safety or effectiveness (Sec.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.
BANZEL (rufinamide) tablet, 100 mg, is the subject of NDA 21-911,
held by Eisai Inc., and initially approved on November 14, 2008. BANZEL
is indicated for adjunctive treatment of seizures associated with
Lennox-Gastaut syndrome in children 4 years and older and adults.
Eisai Inc., has never marketed BANZEL (rufinamide) tablet, 100 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.
Lupin Pharmaceuticals, Inc., submitted a citizen petition dated May
9, 2013 (Docket No. FDA-2013-P-0573), under 21 CFR 10.30, requesting
that the Agency determine whether BANZEL (rufinamide) tablet, 100 mg,
was withdrawn or discontinued 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 BANZEL (rufinamide) tablet, 100 mg, was not
withdrawn for reasons of safety or effectiveness. The petitioner has
identified no data or other information suggesting that BANZEL
(rufinamide) tablet, 100 mg, was withdrawn for reasons of safety or
effectiveness. We have carefully reviewed our files for records
concerning the withdrawal of BANZEL (rufinamide) tablet, 100 mg, from
sale. We have also independently evaluated relevant literature and data
for possible postmarketing adverse events. We have reviewed the
available evidence and determined that this product was not withdrawn
from sale for reasons of safety or effectiveness.
Accordingly, the Agency will continue to list BANZEL (rufinamide)
tablet, 100 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 BANZEL (rufinamide) tablet, 100 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
[[Page 69857]]
to meet current standards, the Agency will advise ANDA applicants to
submit such labeling.
Dated: November 15, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-27874 Filed 11-20-13; 8:45 am]
BILLING CODE 4160-01-P