Determination That CARDENE (Nicardipine Hydrochloride) Injection, 25 Milligrams/10 Milliliters, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 3933-3934 [2020-01062]
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Federal Register / Vol. 85, No. 15 / Thursday, January 23, 2020 / Notices
jbell on DSKJLSW7X2PROD with NOTICES
would otherwise have an unacceptable
level of risk.
Clinically relevant DDIs between an
investigational drug and other drugs
should therefore: (1) Be defined during
drug development as part of an adequate
assessment of the drug’s overall benefit/
risk profile; (2) be known at the time of
the drug’s approval; and (3) be
communicated in labeling. These two
final guidances are intended to assist
drug developers in the planning and
evaluation of DDI potential during drug
development. The in vitro DDI guidance
focuses on in vitro experimental
approaches for evaluating metabolizing
enzyme- and transporter-based drug
interaction potential and how to
extrapolate in vitro data to decide on the
need for clinical DDI studies. The
clinical DDI guidance focuses on
clinical studies that evaluate DDIs that
alter a drug’s pharmacokinetics by
modulating the effects of drug
metabolizing enzymes and/or
transporters and advises sponsors on the
timing and design of the clinical
studies, interpretation of the results, and
options for DDI management in patients.
Revisions to the draft guidances
include clarification on the scope of the
guidances, additional considerations for
prospective drug interaction studies,
and when DDI studies are needed for
drugs identified as transporter
substrates from in vitro studies.
Together, the two final guidances
describe a systematic, risk-based
approach to evaluation and
communication of DDIs.
These guidances are being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidances represent the current
thinking of FDA on the topics they
address. They do not establish any
rights for any person and are not
binding on FDA or the public. You can
use an alternative approach if it satisfies
the requirements of the applicable
statutes and regulations.
II. Paperwork Reduction Act of 1995
These guidances refer to previously
approved collections of information
found in FDA regulations. These
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3521). The collections of information in
21 CFR 314.50(d) have been approved
under OMB control number 0910–0001.
III. Electronic Access
Persons with access to the internet
may obtain the guidance at either
https://www.fda.gov/drugs/guidancecompliance-regulatory-information/
VerDate Sep<11>2014
17:13 Jan 22, 2020
Jkt 250001
guidances-drugs or https://
www.regulations.gov.
Dated: January 16, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–01064 Filed 1–22–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–P–1525]
Determination That CARDENE
(Nicardipine Hydrochloride) Injection,
25 Milligrams/10 Milliliters, 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 CARDENE (nicardipine
hydrochloride) injection, 25 milligrams
(mg)/10 milliliters (mL), was not
withdrawn from sale for reasons of
safety or effectiveness. This
determination will allow FDA to
approve abbreviated new drug
applications (ANDAs) for nicardipine
hydrochloride injection, 25 mg/10 mL,
if all other legal and regulatory
requirements are met.
FOR FURTHER INFORMATION CONTACT:
Daniel Gottlieb, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6210,
Silver Spring, MD 20993–0002, 301–
796–6650, daniel.gottlieb@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
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
SUMMARY:
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Frm 00043
Fmt 4703
Sfmt 4703
3933
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.
CARDENE (nicardipine
hydrochloride) injection, 25 mg/10 mL,
is the subject of NDA 019734, held by
Chiesi USA, Inc., and initially approved
on January 30, 1992. CARDENE is
indicated for short-term treatment of
hypertension when oral therapy is not
feasible or not desirable.
In a letter dated February 13, 2018,
Chiesi USA, Inc. notified FDA that
CARDENE (nicardipine hydrochloride)
injection, 25 mg/10 mL, was being
discontinued, and FDA moved the drug
product to the ‘‘Discontinued Drug
Product List’’ section of the Orange
Book.
Baxter Healthcare Corporation
submitted a citizen petition on May 6,
2019 (Docket No. FDA–2019–P–1525),
under 21 CFR 10.30, requesting that the
Agency determine whether CARDENE
(nicardipine hydrochloride) injection,
25 mg/10 mL, 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
§ 314.161 that CARDENE (nicardipine
hydrochloride) injection, 25 mg/10 mL,
was not withdrawn for reasons of safety
or effectiveness. The petitioner has
identified no data or other information
suggesting that this drug product was
withdrawn for reasons of safety or
effectiveness. We have carefully
reviewed our files for records
concerning the withdrawal of CARDENE
(nicardipine hydrochloride) injection,
25 mg/10 mL, from sale. We have also
independently evaluated relevant
literature and data for possible
postmarketing adverse events. We have
found no information that would
E:\FR\FM\23JAN1.SGM
23JAN1
3934
Federal Register / Vol. 85, No. 15 / Thursday, January 23, 2020 / Notices
indicate that this drug product was
withdrawn from sale for reasons of
safety or effectiveness.
Accordingly, the Agency will
continue to list CARDENE (nicardipine
hydrochloride) injection, 25 mg/10 mL,
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: January 16, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–01062 Filed 1–22–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–1393]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Patent Term
Restoration; Due Diligence Petitions;
Filing, Format, and Content of
Petitions
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by February
24, 2020.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, Fax: 202–
jbell on DSKJLSW7X2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:13 Jan 22, 2020
Jkt 250001
395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0233. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–5733, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Patent Term Restoration; Due Diligence
Petitions; Filing, Format, and Content of
Petitions 21 CFR Part 60
OMB Control Number 0910–0233—
Extension
This information collection supports
Agency regulations. FDA’s patent
extension activities are conducted under
the authority of the Drug Price
Competition and Patent Term
Restoration Act of 1984 (21 U.S.C.
355(j)) and the Generic Animal Drug
and Patent Term Restoration Act of 1988
(35 U.S.C. 156). New human drug,
animal drug, human biological, medical
device, food additive, or color additive
products regulated by FDA must
undergo FDA safety, or safety and
effectiveness review before marketing is
permitted. If the product is covered by
a patent, part of the patent’s term may
be consumed during this review, which
diminishes the value of the patent.
In enacting the Drug Price
Competition and Patent Term
Restoration Act of 1984 and the Generic
Animal Drug and Patent Term
Restoration Act of 1988, Congress
sought to encourage development of
new, safer, and more effective medical
and food additive products. It did so by
authorizing the U.S. Patent and
Trademark Office (USPTO) to extend
the patent term by a portion of the time
during which FDA’s safety and
effectiveness review prevented
marketing of the product. The length of
the patent term extension is generally
limited to a maximum of 5 years and is
calculated by USPTO based on a
statutory formula. When a patent holder
submits an application for patent term
extension to USPTO, USPTO requests
information from FDA, including the
length of the regulatory review period
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
for the patented product. If USPTO
concludes that the product is eligible for
patent term extension, FDA publishes a
notice that describes the length of the
regulatory review period and the dates
used to calculate that period. Interested
parties may request, under § 60.24 (21
CFR 60.24), revision of the length of the
regulatory review period, or may
petition under § 60.30 (21 CFR 60.30) to
reduce the regulatory review period by
any time where marketing approval was
not pursued with ‘‘due diligence.’’
The statute (21 CFR 60.36) defines
due diligence as ‘‘that degree of
attention, continuous directed effort,
and timeliness as may reasonably be
expected from, and are ordinarily
exercised by, a person during a
regulatory review period.’’ As provided
in § 60.30(c), a due diligence petition
‘‘shall set forth sufficient facts,
including dates if possible, to merit an
investigation by FDA of whether the
applicant acted with due diligence.’’
Upon receipt of a due diligence petition,
FDA reviews the petition and evaluates
whether any change in the regulatory
review period is necessary. If so, the
corrected regulatory review period is
published in the Federal Register. A
due diligence petition not satisfied with
FDA’s decision regarding the petition
may, under § 60.40 (21 CFR 60.40),
request an informal hearing for
reconsideration of the due diligence
determination. Petitioners are likely to
include persons or organizations having
knowledge that FDA’s marketing
permission for that product was not
actively pursued throughout the
regulatory review period. The
information collection for which an
extension of approval is being sought is
the use of the statutorily created due
diligence petition.
During the calendar years 2016
through 2018, 16 requests for revision of
the regulatory review period were
submitted under § 60.24(a). In addition,
a total of three due diligence petitions
were submitted under § 60.30. There
have been no requests for hearings
under § 60.40; however, for purposes of
this information collection approval, we
estimate that we may receive one
submission annually.
In the Federal Register of August 21,
2019 (84 FR 43606), we published a 60day notice requesting public comment
on the proposed collection of
information. No comments were
received.
We estimate the burden of this
collection of information as follows:
E:\FR\FM\23JAN1.SGM
23JAN1
]]>Agencies
[Federal Register Volume 85, Number 15 (Thursday, January 23, 2020)]
[Notices]
[Pages 3933-3934]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-01062]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-P-1525]
Determination That CARDENE (Nicardipine Hydrochloride) Injection,
25 Milligrams/10 Milliliters, 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 CARDENE (nicardipine hydrochloride) injection, 25
milligrams (mg)/10 milliliters (mL), was not withdrawn from sale for
reasons of safety or effectiveness. This determination will allow FDA
to approve abbreviated new drug applications (ANDAs) for nicardipine
hydrochloride injection, 25 mg/10 mL, if all other legal and regulatory
requirements are met.
FOR FURTHER INFORMATION CONTACT: Daniel Gottlieb, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6210, Silver Spring, MD 20993-0002, 301-
796-6650, [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.
CARDENE (nicardipine hydrochloride) injection, 25 mg/10 mL, is the
subject of NDA 019734, held by Chiesi USA, Inc., and initially approved
on January 30, 1992. CARDENE is indicated for short-term treatment of
hypertension when oral therapy is not feasible or not desirable.
In a letter dated February 13, 2018, Chiesi USA, Inc. notified FDA
that CARDENE (nicardipine hydrochloride) injection, 25 mg/10 mL, was
being discontinued, and FDA moved the drug product to the
``Discontinued Drug Product List'' section of the Orange Book.
Baxter Healthcare Corporation submitted a citizen petition on May
6, 2019 (Docket No. FDA-2019-P-1525), under 21 CFR 10.30, requesting
that the Agency determine whether CARDENE (nicardipine hydrochloride)
injection, 25 mg/10 mL, 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 CARDENE (nicardipine hydrochloride) injection,
25 mg/10 mL, was not withdrawn for reasons of safety or effectiveness.
The petitioner has identified no data or other information suggesting
that this drug product was withdrawn for reasons of safety or
effectiveness. We have carefully reviewed our files for records
concerning the withdrawal of CARDENE (nicardipine hydrochloride)
injection, 25 mg/10 mL, from sale. We have also independently evaluated
relevant literature and data for possible postmarketing adverse events.
We have found no information that would
[[Page 3934]]
indicate that this drug product was withdrawn from sale for reasons of
safety or effectiveness.
Accordingly, the Agency will continue to list CARDENE (nicardipine
hydrochloride) injection, 25 mg/10 mL, 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: January 16, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-01062 Filed 1-22-20; 8:45 am]
BILLING CODE 4164-01-P
