[Federal Register Volume 84, Number 63 (Tuesday, April 2, 2019)]
[Notices]
[Pages 12616-12617]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-06381]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-P-2754]
Determination That ONFI (Clobazam) Tablets, 5 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Withdrawn From Sale for Reasons of Safety or Effectiveness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 ONFI (clobazam) tablets, 5 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withdrawn from sale for reasons of safety or effectiveness.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) that refer to the drug product, if all other legal
and regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT: Darren Eicken, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave. Bldg. 51, Rm. 6206, Silver Spring, MD 20993-0002, 240-
402-0978.
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
[[Page 12617]]
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drug was withdrawn from sale for reasons of safety or effectiveness (21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.
ONFI (clobazam) tablets, 5 mg, is the subject of NDA 202067, held
by Lundbeck Pharmaceuticals, LLC, and initially approved on October 21,
2011. ONFI is indicated for the adjunctive treatment of seizures
associated with Lennox-Gastaut syndrome in patients 2 years of age or
older.
In a letter dated November 2, 2012, Lundbeck Pharmaceuticals, LLC,
notified FDA that ONFI (clobazam) tablets, 5 mg, was being
discontinued, and FDA moved the drug product to the ``Discontinued Drug
Product List'' section of the Orange Book.
Ascend Laboratories, LLC, submitted a citizen petition dated July
17, 2018 (Docket No. FDA-2018-P-2754), under 21 CFR 10.30, requesting
that the Agency determine whether ONFI (clobazam) tablets, 5 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 ONFI (clobazam) tablets, 5 mg, was not
withdrawn for reasons of safety or effectiveness. The petitioner has
identified no data or other information suggesting that ONFI (clobazam)
tablets, 5 mg, was withdrawn for reasons of safety or effectiveness. We
have carefully reviewed our files for records concerning the withdrawal
of ONFI (clobazam) tablets, 5 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 drug product was not withdrawn from sale for reasons of
safety or effectiveness.
Accordingly, the Agency will continue to list ONFI (clobazam)
tablets, 5 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
this drug product 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: March 27, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-06381 Filed 4-1-19; 8:45 am]
BILLING CODE 4164-01-P