Determination That STAVZOR (Valproic Acid) Delayed-Release Capsules, 125 Milligrams, 250 Milligrams, and 500 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 9225 [2014-03455]
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Federal Register / Vol. 79, No. 32 / Tuesday, February 18, 2014 / Notices
Respondents to this collection of
information are generic animal drug
applicants. Based on data for the past 3
years, FDA estimates there are
approximately 20 submissions annually
and a total of 3.2 burden hours.
Dated: February 10, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–03352 Filed 2–14–14; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–P–0948]
Determination That STAVZOR
(Valproic Acid) Delayed-Release
Capsules, 125 Milligrams, 250
Milligrams, and 500 Milligrams, Was
Not Withdrawn From Sale for Reasons
of Safety or Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) has
determined that STAVZOR (valproic
acid) delayed-release capsules, 125
milligrams (mg), 250 mg, and 500 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was not withdrawn from sale for reasons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 valproic acid,
delayed-release capsules, 125 mg, 250
mg, and 500 mg, if all other legal and
regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT:
Na’Im R. Moses, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6223,
Silver Spring, MD 20993–0002, 240–
402–3990.
SUPPLEMENTARY INFORMATION: In 1984,
Congress enacted the Drug Price
Competition and Patent Term
Restoration Act of 1984 (Public Law 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
tkelley on DSK3SPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
20:58 Feb 14, 2014
Jkt 232001
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 (§ 314.161 (21 CFR 314.161)).
FDA may not approve an ANDA that
does not refer to a listed drug.
STAVZOR (valproic acid) delayedrelease capsules, 125 mg, 250 mg, and
500 mg, is the subject of NDA 22–152,
held by Banner Pharmacaps Inc., and
initially approved on July 29, 2008.
STAVZOR is indicated for acute
treatment of manic or mixed episodes
associated with bipolar disorder (with
or without psychotic features),
monotherapy and adjunctive therapy of
complex partial seizures and simple and
complex absence seizures, adjunctive
therapy in patients with multiple
seizure types that include absence
seizures, and prophylaxis of migraine
headaches.
In a letter dated June 25, 2013, Banner
Pharmacaps Inc. notified FDA that
STAVZOR (valproic acid) delayedrelease capsules, 125 mg, 250 mg, and
500 mg, was being discontinued, and
FDA moved the drug product to the
‘‘Discontinued Drug Product List’’
section of the Orange Book.
Pharmaceutics International, Inc.,
submitted a citizen petition dated
August 7, 2013 (Docket No. FDA–2013–
P–0948), under 21 CFR 10.30,
requesting that the Agency determine
whether STAVZOR (valproic acid)
delayed-release capsules, 125 mg, 250
mg, and 500 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
PO 00000
Frm 00069
Fmt 4703
Sfmt 4703
9225
§ 314.161 that STAVZOR (valproic acid)
delayed-release capsules, 125 mg, 250
mg, and 500 mg, was not withdrawn for
reasons of safety or effectiveness. The
petitioner has identified no data or other
information suggesting that STAVZOR
(valproic acid) delayed-release capsules,
125 mg, 250 mg, and 500 mg, was
withdrawn for reasons of safety or
effectiveness. We have carefully
reviewed our files for records
concerning the withdrawal of
STAVZOR (valproic acid) delayedrelease capsules, 125 mg, 250 mg, and
500 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 product was not
withdrawn from sale for reasons of
safety or effectiveness.
Accordingly, the Agency will
continue to list STAVZOR (valproic
acid) delayed-release capsules, 125 mg,
250 mg, and 500 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 STAVZOR (valproic acid) delayedrelease capsules, 125 mg, 250 mg, and
500 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 12, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–03455 Filed 2–14–14; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0161]
Determination That GANITE (Gallium
Nitrate) Injectable and Five Other Drug
Products Were Not Withdrawn From
Sale for Reasons of Safety or
Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) has determined
SUMMARY:
E:\FR\FM\18FEN1.SGM
18FEN1
]]>Agencies
[Federal Register Volume 79, Number 32 (Tuesday, February 18, 2014)]
[Notices]
[Page 9225]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-03455]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-P-0948]
Determination That STAVZOR (Valproic Acid) Delayed-Release
Capsules, 125 Milligrams, 250 Milligrams, and 500 Milligrams, Was Not
Withdrawn From Sale for Reasons of Safety or Effectiveness
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or the Agency) has
determined that STAVZOR (valproic acid) delayed-release capsules, 125
milligrams (mg), 250 mg, and 500 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 valproic acid,
delayed-release capsules, 125 mg, 250 mg, and 500 mg, if all other
legal and regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT: Na'Im R. Moses, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6223, Silver Spring, MD 20993-0002, 240-
402-3990.
SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price
Competition and Patent Term Restoration Act of 1984 (Public Law 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 (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.
STAVZOR (valproic acid) delayed-release capsules, 125 mg, 250 mg,
and 500 mg, is the subject of NDA 22-152, held by Banner Pharmacaps
Inc., and initially approved on July 29, 2008. STAVZOR is indicated for
acute treatment of manic or mixed episodes associated with bipolar
disorder (with or without psychotic features), monotherapy and
adjunctive therapy of complex partial seizures and simple and complex
absence seizures, adjunctive therapy in patients with multiple seizure
types that include absence seizures, and prophylaxis of migraine
headaches.
In a letter dated June 25, 2013, Banner Pharmacaps Inc. notified
FDA that STAVZOR (valproic acid) delayed-release capsules, 125 mg, 250
mg, and 500 mg, was being discontinued, and FDA moved the drug product
to the ``Discontinued Drug Product List'' section of the Orange Book.
Pharmaceutics International, Inc., submitted a citizen petition
dated August 7, 2013 (Docket No. FDA-2013-P-0948), under 21 CFR 10.30,
requesting that the Agency determine whether STAVZOR (valproic acid)
delayed-release capsules, 125 mg, 250 mg, and 500 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 STAVZOR (valproic acid) delayed-release
capsules, 125 mg, 250 mg, and 500 mg, was not withdrawn for reasons of
safety or effectiveness. The petitioner has identified no data or other
information suggesting that STAVZOR (valproic acid) delayed-release
capsules, 125 mg, 250 mg, and 500 mg, was withdrawn for reasons of
safety or effectiveness. We have carefully reviewed our files for
records concerning the withdrawal of STAVZOR (valproic acid) delayed-
release capsules, 125 mg, 250 mg, and 500 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 product was not withdrawn from sale for reasons of
safety or effectiveness.
Accordingly, the Agency will continue to list STAVZOR (valproic
acid) delayed-release capsules, 125 mg, 250 mg, and 500 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 STAVZOR (valproic
acid) delayed-release capsules, 125 mg, 250 mg, and 500 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 12, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-03455 Filed 2-14-14; 8:45 am]
BILLING CODE 4160-01-P
