Determination That TENEX (Guanfacine Hydrochloride) Tablets, 1 Milligram, 2 Milligrams, and 3 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 37953 [2020-13594]
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Federal Register / Vol. 85, No. 122 / Wednesday, June 24, 2020 / Notices
Number of
respondents
Respondent/data collection activity
Conference Evaluation ......................................................................
Dated: June 17, 2020.
Mary Lazare,
Principal Deputy Administrator.
[FR Doc. 2020–13575 Filed 6–23–20; 8:45 am]
BILLING CODE 4154–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–P–0813]
Determination That TENEX
(Guanfacine Hydrochloride) Tablets, 1
Milligram, 2 Milligrams, and 3
Milligrams, Was Not Withdrawn From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 Agency) has
determined that TENEX (guanfacine
hydrochloride) tablets, 1 milligram (mg),
2 mg, and 3 mg, was not withdrawn
from sale for reasons of safety or
effectiveness. This determination means
that FDA will not begin procedures to
withdraw approval of abbreviated new
drug applications (ANDAs) that refer to
this drug product, and it will allow FDA
to continue to approve ANDAs that refer
to the product as long as they meet
relevant legal and regulatory
requirements.
SUMMARY:
jbell on DSKJLSW7X2PROD with NOTICES
FOR FURTHER INFORMATION CONTACT:
Jessica Tierney, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6213,
Silver Spring, MD 20993–0002, 301–
796–9120, Jessica.Tierney@fda.hhs.gov.
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
VerDate Sep<11>2014
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364
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 (§ 314.161 (21 CFR 314.161)).
FDA may not approve an ANDA that
does not refer to a listed drug.
TENEX (guanfacine hydrochloride)
tablets, 1 mg, 2 mg, and 3 mg, is the
subject of NDA 019032, held by Promius
Pharma LLC, and initially approved on
October 27, 1996. TENEX is indicated in
the management of hypertension.
TENEX (guanfacine hydrochloride)
tablets, 1 mg, 2 mg, and 3 mg, is
currently listed in the ‘‘Discontinued
Drug Product List’’ section of the Orange
Book. Unichem Pharmaceuticals (USA),
Inc. submitted a citizen petition dated
February 13, 2020 (Docket No. FDA–
2020–P–0813), under 21 CFR 10.30,
requesting that the Agency determine
whether TENEX (guanfacine
hydrochloride) tablets, 1 mg and 2 mg,
was withdrawn from sale for reasons of
safety or effectiveness. Although the
citizen petition did not address the 3 mg
strength, that strength has also been
discontinued. On our own initiative, we
have also determined whether that
strength was withdrawn for safety or
effectiveness reasons.
After considering the citizen petition
and reviewing Agency records and
based on the information we have at this
time, FDA has determined under
§ 314.161 that TENEX (guanfacine
hydrochloride) tablets, 1 mg, 2 mg, and
PO 00000
Frm 00134
Fmt 4703
Sfmt 9990
37953
Annual burden
hours
91
3 mg, was not withdrawn for reasons of
safety or effectiveness. The petitioner
has identified no data or other
information suggesting that TENEX
(guanfacine hydrochloride) tablets, 1
mg, 2 mg, and 3 mg, was withdrawn for
reasons of safety or effectiveness. We
have carefully reviewed our files for
records concerning the withdrawal of
TENEX (guanfacine hydrochloride)
tablets, 1 mg, 2 mg, and 3 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 TENEX (guanfacine
hydrochloride) tablets, 1 mg, 2 mg, and
3 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. FDA
will not begin procedures to withdraw
approval of approved ANDAs that refer
to this drug product. Additional ANDAs
for this drug product may also 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: June 18, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–13594 Filed 6–23–20; 8:45 am]
BILLING CODE 4164–01–P
E:\FR\FM\24JNN1.SGM
24JNN1
]]>Agencies
[Federal Register Volume 85, Number 122 (Wednesday, June 24, 2020)]
[Notices]
[Page 37953]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-13594]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-P-0813]
Determination That TENEX (Guanfacine Hydrochloride) Tablets, 1
Milligram, 2 Milligrams, and 3 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 Agency) has
determined that TENEX (guanfacine hydrochloride) tablets, 1 milligram
(mg), 2 mg, and 3 mg, was not withdrawn from sale for reasons of safety
or effectiveness. This determination means that FDA will not begin
procedures to withdraw approval of abbreviated new drug applications
(ANDAs) that refer to this drug product, and it will allow FDA to
continue to approve ANDAs that refer to the product as long as they
meet relevant legal and regulatory requirements.
FOR FURTHER INFORMATION CONTACT: Jessica Tierney, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6213, Silver Spring, MD 20993-0002, 301-
796-9120, [email protected].
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 (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.
TENEX (guanfacine hydrochloride) tablets, 1 mg, 2 mg, and 3 mg, is
the subject of NDA 019032, held by Promius Pharma LLC, and initially
approved on October 27, 1996. TENEX is indicated in the management of
hypertension.
TENEX (guanfacine hydrochloride) tablets, 1 mg, 2 mg, and 3 mg, is
currently listed in the ``Discontinued Drug Product List'' section of
the Orange Book. Unichem Pharmaceuticals (USA), Inc. submitted a
citizen petition dated February 13, 2020 (Docket No. FDA-2020-P-0813),
under 21 CFR 10.30, requesting that the Agency determine whether TENEX
(guanfacine hydrochloride) tablets, 1 mg and 2 mg, was withdrawn from
sale for reasons of safety or effectiveness. Although the citizen
petition did not address the 3 mg strength, that strength has also been
discontinued. On our own initiative, we have also determined whether
that strength was withdrawn for safety or effectiveness reasons.
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 TENEX (guanfacine hydrochloride) tablets, 1
mg, 2 mg, and 3 mg, was not withdrawn for reasons of safety or
effectiveness. The petitioner has identified no data or other
information suggesting that TENEX (guanfacine hydrochloride) tablets, 1
mg, 2 mg, and 3 mg, was withdrawn for reasons of safety or
effectiveness. We have carefully reviewed our files for records
concerning the withdrawal of TENEX (guanfacine hydrochloride) tablets,
1 mg, 2 mg, and 3 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 TENEX (guanfacine
hydrochloride) tablets, 1 mg, 2 mg, and 3 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. FDA will not begin procedures to withdraw approval of
approved ANDAs that refer to this drug product. Additional ANDAs for
this drug product may also 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: June 18, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-13594 Filed 6-23-20; 8:45 am]
BILLING CODE 4164-01-P
