Determination That VOTRIENT (Pazopanib Hydrochloride) Tablets, 400 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 42843 [2021-16692]
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Federal Register / Vol. 86, No. 148 / Thursday, August 5, 2021 / Notices
and adjust results based on those
factors.
The mode experiment is designed to
examine the effects of the shortened
survey on response rates and scores and
to provide precise adjustment estimates
for survey items and composites on the
shortened survey instrument.
Information from this mode experiment
will help CMS determine whether an
additional mode of administration (i.e.,
Web data collection) should be included
and a shortened survey instrument
should be used in the current national
implementation of the HHCAHPS
Survey. Form Number: CMS–10784
(OMB control number: 0938–New);
Frequency: Annually; Affected Public:
Individuals or Households; Number of
Respondents: 6,280; Total Annual
Responses: 6,280; Total Annual Hours:
1,049. (For policy questions regarding
this collection contact Lori E. Teichman
at 410–786–6684).
Dated: August 2, 2021.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2021–16755 Filed 8–4–21; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2021–P–0271]
Determination That VOTRIENT
(Pazopanib Hydrochloride) Tablets,
400 Milligrams, Were Not Withdrawn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 or Agency) has
determined that VOTRIENT (pazopanib
hydrochloride) tablets, 400 milligrams
(mg), were not withdrawn from sale for
reasons of safety or effectiveness. This
determination will allow FDA to
approve abbreviated new drug
applications (ANDAs) for pazopanib
hydrochloride tablets, 400 mg, if all
other legal and regulatory requirements
are met.
FOR FURTHER INFORMATION CONTACT:
Sungjoon Chi, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6212,
Silver Spring, MD 20993–0002, 240–
402–9674, Sungjoon.Chi@fda.hhs.gov.
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:07 Aug 04, 2021
Jkt 253001
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 (§ 314.161 (21 CFR 314.161)).
FDA may not approve an ANDA that
does not refer to a listed drug.
VOTRIENT (pazopanib
hydrochloride) tablets, 400 mg, are the
subject of NDA 022465, held by
Novartis Pharmaceuticals Corp., and
initially approved on October 19, 2009.
VOTRIENT is a kinase inhibitor
indicated for the treatment of patients
with advanced renal cell carcinoma.
VOTRIENT (pazopanib hydrochloride)
tablets, 400 mg, are currently listed in
the ‘‘Discontinued Drug Product List’’
section of the Orange Book.
Hyman, Phelps & McNamara, P.C.,
submitted a citizen petition dated
March 5, 2021 (Docket No. FDA–2021–
P–0271), under 21 CFR 10.30,
requesting that the Agency determine
whether VOTRIENT (pazopanib
hydrochloride) tablets, 400 mg, were
withdrawn from sale for reasons of
safety or effectiveness.
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00068
Fmt 4703
Sfmt 4703
42843
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 VOTRIENT (pazopanib
hydrochloride) tablets, 400 mg, were not
withdrawn for reasons of safety or
effectiveness. The petitioner has
identified no data or other information
suggesting that VOTRIENT (pazopanib
hydrochloride) tablets, 400 mg, were
withdrawn for reasons of safety or
effectiveness. We have carefully
reviewed our files for records
concerning the withdrawal of
VOTRIENT (pazopanib hydrochloride)
tablets, 400 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 VOTRIENT (pazopanib
hydrochloride) tablets, 400 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 VOTRIENT (pazopanib
hydrochloride) tablets, 400 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: July 29, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–16692 Filed 8–4–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–3741]
Remanufacturing of Medical Devices;
Draft Guidance for Industry and Food
and Drug Administration Staff;
Availability; Extension of Comment
Period
Food and Drug Administration,
Health and Human Services (HHS).
ACTION: Notice of availability; extension
of comment period.
AGENCY:
E:\FR\FM\05AUN1.SGM
05AUN1
]]>Agencies
[Federal Register Volume 86, Number 148 (Thursday, August 5, 2021)]
[Notices]
[Page 42843]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-16692]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-P-0271]
Determination That VOTRIENT (Pazopanib Hydrochloride) Tablets,
400 Milligrams, Were 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 VOTRIENT (pazopanib hydrochloride) tablets, 400
milligrams (mg), were not withdrawn from sale for reasons of safety or
effectiveness. This determination will allow FDA to approve abbreviated
new drug applications (ANDAs) for pazopanib hydrochloride tablets, 400
mg, if all other legal and regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT: Sungjoon Chi, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6212, Silver Spring, MD 20993-0002, 240-
402-9674, [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.
VOTRIENT (pazopanib hydrochloride) tablets, 400 mg, are the subject
of NDA 022465, held by Novartis Pharmaceuticals Corp., and initially
approved on October 19, 2009. VOTRIENT is a kinase inhibitor indicated
for the treatment of patients with advanced renal cell carcinoma.
VOTRIENT (pazopanib hydrochloride) tablets, 400 mg, are currently
listed in the ``Discontinued Drug Product List'' section of the Orange
Book.
Hyman, Phelps & McNamara, P.C., submitted a citizen petition dated
March 5, 2021 (Docket No. FDA-2021-P-0271), under 21 CFR 10.30,
requesting that the Agency determine whether VOTRIENT (pazopanib
hydrochloride) tablets, 400 mg, were 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 VOTRIENT (pazopanib hydrochloride) tablets,
400 mg, were not withdrawn for reasons of safety or effectiveness. The
petitioner has identified no data or other information suggesting that
VOTRIENT (pazopanib hydrochloride) tablets, 400 mg, were withdrawn for
reasons of safety or effectiveness. We have carefully reviewed our
files for records concerning the withdrawal of VOTRIENT (pazopanib
hydrochloride) tablets, 400 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 VOTRIENT (pazopanib
hydrochloride) tablets, 400 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 VOTRIENT (pazopanib hydrochloride)
tablets, 400 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: July 29, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-16692 Filed 8-4-21; 8:45 am]
BILLING CODE 4164-01-P
