Determination That LOTENSIN HCT (Benazepril Hydrochloride; Hydrochlorothiazide) Oral Tablets, 5 Milligrams and 6.25 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 7046-7047 [2018-03188]
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Federal Register / Vol. 83, No. 33 / Friday, February 16, 2018 / Notices
additional work. The applicant would
likely perform more quality assurance,
which may add time to preparation and
review of the submission.
Based on CDER’s data on the number
of NDAs, BLAs, and NDA and BLA
supplemental applications containing
new clinical study reports that would be
covered by the draft guidance, we
estimate that each year approximately
75 applicants will submit for 125
original NDA or BLA applications and
152 supplemental applications
containing new clinical study reports.
We estimate that the submission of the
clinical study-level information, subjectlevel data line listings by clinical site,
and the summary-level clinical site
dataset for each application would take
approximately 40 hours to prepare.
Initial preparation of the clinical studylevel information, subject-level data line
listings by clinical site, and the
summary-level clinical site dataset
could involve the development of new
SOPs for some applicants. We estimate
that 75 applicants would take
approximately 20 hours to develop and
subsequently 2 hours annually to
maintain and update the SOP(s). The
clinical study-level information, subjectlevel data line listings by clinical site,
and the summary-level clinical site
dataset submitted with each application
would likely involve additional quality
assurance procedures, which would add
approximately 2 hours for each
submission.
This draft guidance also refers to
previously approved collections of
information found in FDA regulations.
The collections of information in part
312 have been approved under OMB
control number 0910–0014; the
collections of information in part 314
have been approved under OMB control
number 0910–0001; the collections of
information in part 601 have been
approved under OMB control number
0910–0338.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED REPORTING BURDEN 1
Number of
responses per
respondent
(i.e., applications)
Number of
respondents
(i.e., applicants)
Activity
Total
responses
Hours per
response
Total hours
Submissions (clinical study-level information,
subject-level data line listings by clinical
site, and the summary-level clinical site
dataset) .........................................................
Quality Assurance ............................................
75
75
3.7
3.7
277
277
40
2
11,080
554
Total ..........................................................
................................
....................................
........................
........................
11,634
1 There
are no capital costs or operating and maintenance costs associated with this information collection.
TABLE 2—ESTIMATED RECORDKEEPING BURDEN 1
Number of
recordkeepers
Activity
Number of
records per
recordkeeper
Total
records
Hours per
recordkeeper
Total hours
Develop Initial SOP(s) .........................................................
Maintain and Update SOP(s) ...............................................
75
75
1
1
75
75
20
2
1,500
150
Total ..............................................................................
........................
........................
........................
........................
1,650
1 There
are no capital costs or operating and maintenance costs associated with this information collection.
II. Electronic Access
Persons with access to the internet
may obtain the draft guidance at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
Dated: February 9, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–03236 Filed 2–15–18; 8:45 am]
Food and Drug Administration
[Docket No. FDA–2017–P–4852]
Determination That LOTENSIN HCT
(Benazepril Hydrochloride;
Hydrochlorothiazide) Oral Tablets, 5
Milligrams and 6.25 Milligrams, Were
Not Withdrawn From Sale for Reasons
of Safety or Effectiveness
AGENCY:
BILLING CODE 4164–01–P
daltland on DSKBBV9HB2PROD with NOTICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) has
determined that LOTENSIN HCT
(benazepril hydrochloride;
hydrochlorothiazide) oral tablets, 5
milligrams (mg) and 6.25 mg, were not
SUMMARY:
VerDate Sep<11>2014
19:24 Feb 15, 2018
Jkt 244001
PO 00000
Frm 00039
Fmt 4703
Sfmt 4703
withdrawn from sale for reasons of
safety or effectiveness. This
determination will allow FDA to
approve abbreviated new drug
applications (ANDAs) for benazepril
hydrochloride; hydrochlorothiazide oral
tablets, 5 mg and 6.25 mg, if all other
legal and regulatory requirements are
met.
FOR FURTHER INFORMATION CONTACT:
Stacy Kane, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 6236, Silver Spring,
MD 20993–0002, 301–796–8363,
Stacy.Kane@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
E:\FR\FM\16FEN1.SGM
16FEN1
daltland on DSKBBV9HB2PROD with NOTICES
Federal Register / Vol. 83, No. 33 / Friday, February 16, 2018 / Notices
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.
LOTENSIN HCT (benazepril
hydrochloride; hydrochlorothiazide)
oral tablets, 5 mg and 6.25 mg, are the
subject of NDA 020033, held by U.S.
Pharmaceutical Holdings I, LLC, and
initially approved on May 19, 1992.
LOTENSIN HCT is indicated for the
relief of symptoms of depression.
LOTENSIN HCT (benazepril
hydrochloride; hydrochlorothiazide)
oral tablets, 5 mg and 6.25 mg, are
currently listed in the ‘‘Discontinued
Drug Product List’’ section of the Orange
Book.
EAS Consulting Group, LLC
submitted a citizen petition dated
August 9, 2017 (Docket No. FDA–2017–
P–4852), under 21 CFR 10.30,
requesting that the Agency determine
whether LOTENSIN HCT (benazepril
hydrochloride; hydrochlorothiazide)
oral tablets, 5 mg and 6.25 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
VerDate Sep<11>2014
19:24 Feb 15, 2018
Jkt 244001
time, FDA has determined under
§ 314.161 that LOTENSIN HCT
(benazepril hydrochloride;
hydrochlorothiazide) oral tablets, 5 mg
and 6.25 mg, were not withdrawn for
reasons of safety or effectiveness. The
petitioner has identified no data or other
information suggesting that these
products were withdrawn for reasons of
safety or effectiveness. We have
carefully reviewed our files for records
concerning the withdrawal of
LOTENSIN HCT (benazepril
hydrochloride; hydrochlorothiazide)
oral tablets, 5 mg and 6.25 mg, from
sale. We have also independently
evaluated relevant literature and data
for possible post-marketing 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 LOTENSIN HCT
(benazepril hydrochloride;
hydrochlorothiazide) oral tablets, 5 mg
and 6.25 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 LOTENSIN HCT
(benazepril hydrochloride;
hydrochlorothiazide) oral tablets, 5 mg
and 6.25 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 9, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–03188 Filed 2–15–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0035]
Amyotrophic Lateral Sclerosis:
Developing Drugs for Treatment; Draft
Guidance for Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
SUMMARY:
PO 00000
Frm 00040
Fmt 4703
Sfmt 4703
7047
announcing the availability of a draft
guidance for industry entitled
‘‘Amyotrophic Lateral Sclerosis:
Developing Drugs for Treatment.’’ The
purpose of this guidance is to assist
sponsors in the clinical development of
drugs for the treatment of amyotrophic
lateral sclerosis (ALS). Specifically, it
addresses FDA’s current thinking
regarding the clinical development
program and clinical trial designs for
drugs to support an indication for the
treatment of ALS. This guidance
addresses the clinical development of
drugs intended to treat the main
neuromuscular aspects of ALS (i.e.,
muscle weakness and its direct
consequences, including shortened
survival).
Submit either electronic or
written comments on the draft guidance
by April 17, 2018 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
DATES:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
E:\FR\FM\16FEN1.SGM
16FEN1
]]>Agencies
[Federal Register Volume 83, Number 33 (Friday, February 16, 2018)]
[Notices]
[Pages 7046-7047]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-03188]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-P-4852]
Determination That LOTENSIN HCT (Benazepril Hydrochloride;
Hydrochlorothiazide) Oral Tablets, 5 Milligrams and 6.25 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 LOTENSIN HCT (benazepril hydrochloride;
hydrochlorothiazide) oral tablets, 5 milligrams (mg) and 6.25 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 benazepril hydrochloride; hydrochlorothiazide
oral tablets, 5 mg and 6.25 mg, if all other legal and regulatory
requirements are met.
FOR FURTHER INFORMATION CONTACT: Stacy Kane, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, Rm. 6236, Silver Spring, MD 20993-0002, 301-796-8363,
[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
[[Page 7047]]
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.
LOTENSIN HCT (benazepril hydrochloride; hydrochlorothiazide) oral
tablets, 5 mg and 6.25 mg, are the subject of NDA 020033, held by U.S.
Pharmaceutical Holdings I, LLC, and initially approved on May 19, 1992.
LOTENSIN HCT is indicated for the relief of symptoms of depression.
LOTENSIN HCT (benazepril hydrochloride; hydrochlorothiazide) oral
tablets, 5 mg and 6.25 mg, are currently listed in the ``Discontinued
Drug Product List'' section of the Orange Book.
EAS Consulting Group, LLC submitted a citizen petition dated August
9, 2017 (Docket No. FDA-2017-P-4852), under 21 CFR 10.30, requesting
that the Agency determine whether LOTENSIN HCT (benazepril
hydrochloride; hydrochlorothiazide) oral tablets, 5 mg and 6.25 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 LOTENSIN HCT (benazepril hydrochloride;
hydrochlorothiazide) oral tablets, 5 mg and 6.25 mg, were not withdrawn
for reasons of safety or effectiveness. The petitioner has identified
no data or other information suggesting that these products were
withdrawn for reasons of safety or effectiveness. We have carefully
reviewed our files for records concerning the withdrawal of LOTENSIN
HCT (benazepril hydrochloride; hydrochlorothiazide) oral tablets, 5 mg
and 6.25 mg, from sale. We have also independently evaluated relevant
literature and data for possible post-marketing 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 LOTENSIN HCT
(benazepril hydrochloride; hydrochlorothiazide) oral tablets, 5 mg and
6.25 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
LOTENSIN HCT (benazepril hydrochloride; hydrochlorothiazide) oral
tablets, 5 mg and 6.25 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 9, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-03188 Filed 2-15-18; 8:45 am]
BILLING CODE 4164-01-P
