Determination That THALITONE (Chlorthalidone USP) Tablets, 15 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 24107-24108 [2016-09450]
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Federal Register / Vol. 81, No. 79 / Monday, April 25, 2016 / Notices
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FOR FURTHER INFORMATION CONTACT: Ebla
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796–6440.
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SUPPLEMENTARY INFORMATION:
II. Paperwork Reduction Act of 1995
I. Background
This revised draft guidance refers to
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(OMB) under the Paperwork Reduction
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FDA is announcing the availability of
a revised draft guidance for industry
entitled ‘‘Assay Development and
Validation for Immunogenicity Testing
of Therapeutic Protein Products.’’
Patient immune responses to
therapeutic protein products have the
potential to affect product safety and
efficacy. The clinical effects of patient
immune responses are highly variable,
ranging from no effect at all to extreme
harmful effects to patient health.
Detection and analysis of ADA
formation is a helpful tool in
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responses observed during clinical
trials, particularly the incidence of ADA
induction and the implications of ADA
responses for drug safety and efficacy, is
crucial for any therapeutic product
development program. Accordingly,
such information, if applicable, should
be included in the prescribing
information as a subsection of the
ADVERSE REACTIONS section entitled
‘‘Immunogenicity.’’
In general, assays for detection of
ADA facilitate understanding of the
immunogenicity, safety, and efficacy of
therapeutic protein products. However,
the detection of ADA is dependent on
key operating parameters of the assays
(e.g., sensitivity, specificity), which vary
between assays. Therefore, the
development of valid, sensitive,
specific, and selective assays to measure
ADA responses is a key aspect of
therapeutic protein product
development.
This guidance revises the draft
guidance for industry entitled ‘‘Assay
Development for Immunogenicity
Testing of Therapeutic Proteins’’ issued
in December 2009. The information in
the draft guidance has been reorganized
for clarity, and the revised draft
guidance includes new information on
titering and confirmatory assays.
This revised draft guidance is being
issued consistent with FDA’s good
guidance practices regulation (21 CFR
10.115). The revised draft guidance,
when finalized, will represent the
current thinking of FDA on assay
development and validation for
immunogenicity testing of therapeutic
protein products. It does not establish
any rights for any person and is not
binding on FDA or the public. You can
use an alternative approach if it satisfies
the requirements of the applicable
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III. Electronic Access
Persons with access to the Internet
may obtain the document at https://
www.fda.gov/Drugs/
GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm, or https://www.fda.gov/
BiologicsBloodVaccines/
GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm, or https://www.fda.gov/
MedicalDevices/DeviceRegulationand
Guidance/GuidanceDocuments/
default.htm, or https://
www.regulations.gov.
Dated: April 19, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–09449 Filed 4–22–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–P–3299]
Determination That THALITONE
(Chlorthalidone USP) Tablets, 15
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 THALITONE
(chlorthalidone USP) tablets, 15
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
SUMMARY:
E:\FR\FM\25APN1.SGM
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asabaliauskas on DSK3SPTVN1PROD with NOTICES
24108
Federal Register / Vol. 81, No. 79 / Monday, April 25, 2016 / Notices
chlorthalidone USP tablets, 15 mg, if all
other legal and regulatory requirements
are met.
FOR FURTHER INFORMATION CONTACT:
Christopher Koepke, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6214,
Silver Spring, MD 20993–0002, 240–
402–3543.
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 (§ 314.161 (21 CFR 314.161)).
FDA may not approve an ANDA that
does not refer to a listed drug.
THALITONE (chlorthalidone USP)
tablets, 15 mg, are the subject of NDA
19–574, held by Citron Pharma LLC,
and initially approved on December 20,
1988. THALITONE is indicated for the
management of hypertension either
alone or in combination with other
antihypertensive drugs. Chlorthalidone
is indicated as an adjunctive therapy in
edema associated with congestive heart
VerDate Sep<11>2014
19:02 Apr 22, 2016
Jkt 238001
failure, hepatic cirrhosis, and
corticosteroid and estrogen therapy.
Chlorthalidone has also been found
useful in edema due to various forms of
renal dysfunction such as nephrotic
syndrome, acute glomerulonephritis,
and chronic renal failure.
THALITONE (chlorthalidone USP)
tablets, 15 mg, are currently listed in the
‘‘Discontinued Drug Product List’’
section of the Orange Book.
Clinipace Worldwide submitted a
citizen petition dated September 9, 2015
(Docket No. FDA–2015–P–3299), under
21 CFR 10.30, requesting that the
Agency determine whether
THALITONE (chlorthalidone USP)
tablets, 15 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, FDA has
determined under § 314.161 that
THALITONE (chlorthalidone USP)
tablets, 15 mg, were not withdrawn for
reasons of safety or effectiveness. The
petitioner has identified no data or other
information suggesting that
THALITONE (chlorthalidone USP)
tablets, 15 mg, were withdrawn for
reasons of safety or effectiveness. We
have carefully reviewed our files for
records concerning the withdrawal of
THALITONE (chlorthalidone USP)
tablets, 15 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 THALITONE
(chlorthalidone USP) tablets, 15 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 THALITONE (chlorthalidone USP)
tablets, 15 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: April 19, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–09450 Filed 4–22–16; 8:45 am]
BILLING CODE 4164–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Indian Health Service
Request for Public Comment: 60-Day
Information Collection: Indian SelfDetermination and Education
Assistance Act Contracts
Indian Health Service, HHS.
Notice and request for
comments. Request for extension of
approval.
AGENCY:
ACTION:
In compliance the Paperwork
Reduction Act of 1995, the Indian
Health Service (IHS) invites the general
public to comment on the information
collection titled, ‘‘Indian SelfDetermination and Education
Assistance Act Contracts,’’ Office of
Management and Budget (OMB) Control
Number 0917–0037. IHS is requesting
OMB to approve an extension for this
collection, which expires on July 31,
2016.
SUMMARY:
Comment Due Date: June 24,
2016. Your comments regarding this
information collection are best assured
of having full effect if received within
60 days of the date of this publication.
ADDRESSES: Send your written
comments, requests for more
information on the collection, or
requests to obtain a copy of the data
collection instrument and instructions
to Mr. Chris Buchanan by one of the
following methods:
• Mail: Mr. Chris Buchanan, Director,
IHS Office of Direct Services and
Contracting Tribes (ODSCT), Indian
Health Service, 5600 Fishers Lane, Mail
Stop O8E17C, Rockville, MD 20857.
• Phone: 301–443–1104.
• Email: Chris.Buchanan@ihs.gov.
• Fax: 301–480–3192.
SUPPLEMENTARY INFORMATION: This
previously approved information
collection project was last published in
the Federal Register (78 FR 32405), as
a joint submission with the Bureau of
Indian Affairs (BIA), under OMB
Control Number 1076–0136, on May 30,
2013 and allowed 30 days for public
comment. No public comment was
received in response to the notice. On
July 31, 2013, the IHS obtained its own
OMB Control Number, 0917–0037, for
this information collection and is now
publishing a separate notice from the
BIA in the Federal Register. The
purpose of this notice is to allow 60
days for public comment. A copy of the
supporting statement is available at
www.regulations.gov (see Docket ID
IHS–2016–0003).
DATES:
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]]>Agencies
[Federal Register Volume 81, Number 79 (Monday, April 25, 2016)]
[Notices]
[Pages 24107-24108]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-09450]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-P-3299]
Determination That THALITONE (Chlorthalidone USP) Tablets, 15
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 THALITONE (chlorthalidone USP) tablets, 15 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
[[Page 24108]]
chlorthalidone USP tablets, 15 mg, if all other legal and regulatory
requirements are met.
FOR FURTHER INFORMATION CONTACT: Christopher Koepke, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6214, Silver Spring, MD 20993-0002, 240-
402-3543.
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.
THALITONE (chlorthalidone USP) tablets, 15 mg, are the subject of
NDA 19-574, held by Citron Pharma LLC, and initially approved on
December 20, 1988. THALITONE is indicated for the management of
hypertension either alone or in combination with other antihypertensive
drugs. Chlorthalidone is indicated as an adjunctive therapy in edema
associated with congestive heart failure, hepatic cirrhosis, and
corticosteroid and estrogen therapy. Chlorthalidone has also been found
useful in edema due to various forms of renal dysfunction such as
nephrotic syndrome, acute glomerulonephritis, and chronic renal
failure.
THALITONE (chlorthalidone USP) tablets, 15 mg, are currently listed
in the ``Discontinued Drug Product List'' section of the Orange Book.
Clinipace Worldwide submitted a citizen petition dated September 9,
2015 (Docket No. FDA-2015-P-3299), under 21 CFR 10.30, requesting that
the Agency determine whether THALITONE (chlorthalidone USP) tablets, 15
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, FDA has determined under Sec. 314.161
that THALITONE (chlorthalidone USP) tablets, 15 mg, were not withdrawn
for reasons of safety or effectiveness. The petitioner has identified
no data or other information suggesting that THALITONE (chlorthalidone
USP) tablets, 15 mg, were withdrawn for reasons of safety or
effectiveness. We have carefully reviewed our files for records
concerning the withdrawal of THALITONE (chlorthalidone USP) tablets, 15
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 THALITONE
(chlorthalidone USP) tablets, 15 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 THALITONE (chlorthalidone USP)
tablets, 15 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: April 19, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-09450 Filed 4-22-16; 8:45 am]
BILLING CODE 4164-01-P
