Determination That NIPRIDE RTU (Sodium Nitroprusside), 10 Milligrams/50 Milliliters (0.2 Milligrams/Milliliters), Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 14451-14452 [2021-05324]
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Federal Register / Vol. 86, No. 49 / Tuesday, March 16, 2021 / Notices
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852, 240–402–7500.
FOR FURTHER INFORMATION CONTACT:
Nicole Park, Office of Generic Drugs,
Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Rm. 1670, Silver Spring, MD
20993–0002, 240–402–7764.
SUPPLEMENTARY INFORMATION: In the
Federal Register of June 1, 2020 (85 FR
33169), FDA published a notice with a
90-day comment period to solicit
comments on the listing of patent
information in the FDA publication
‘‘Approved Drug Products With
Therapeutic Equivalence Evaluations’’
(commonly known as the ‘‘Orange
Book’’), including comments on the
types of patent information that should
be included in the Orange Book. In the
Federal Register of October 16, 2020 (85
FR 65819), FDA reopened the comment
period for the public docket for an
additional 30 days in response to a
request for an extension to allow
interested persons additional time to
submit comments.
On January 5, 2021, the President
signed into law the Orange Book
Transparency Act of 2020 (Pub. L. 116–
290). Section 2(e) of the Orange Book
Transparency Act of 2020 requires the
Agency to solicit public comment
regarding the types of patent
information that should be included on,
or removed from, the Orange Book and
to transmit to Congress a summary of
such comments and actions the Agency
is considering taking, if any, in response
to such public comment by January 5,
2022.
In accordance with section 2(e) of the
Orange Book Transparency Act of 2020,
FDA is reopening the comment period
for the public docket for 30 days, until
April 15, 2021, to allow interested
persons time to submit any additional
comments regarding the types of patent
information that should be included on,
or removed from, the Orange Book. The
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16:52 Mar 15, 2021
Jkt 253001
Agency believes that an additional 30
days will allow adequate time for
interested persons to submit comments.
Dated: March 9, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–05327 Filed 3–15–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–P–1678]
Determination That NIPRIDE RTU
(Sodium Nitroprusside), 10 Milligrams/
50 Milliliters (0.2 Milligrams/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 NIPRIDE RTU (sodium
nitroprusside), 10 milligrams (mg)/50
milliliters (mL) (0.2 mg/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 sodium
nitroprusside, 10 mg/50 mL (0.2 mg/
mL), if all other legal and regulatory
requirements are met.
FOR FURTHER INFORMATION CONTACT:
Michael Bernstein, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6240,
Silver Spring, MD 20993–0002, 301–
796–3478, michael.bernstein@
fda.hhs.gov.
SUMMARY:
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).
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
14451
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.
NIPRIDE RTU (sodium nitroprusside),
10 mg/50 mL (0.2 mg/mL), is the subject
of NDA 209387, held by Exela Pharma
Sciences, LLC, and initially approved
on March 8, 2017. NIPRIDE RTU is
indicated for immediate reduction of
blood pressure of adult and pediatric
patients in hypertensive crises;
induction and maintenance of
controlled hypotension in adults and
children during surgery, to reduce
bleeding; and treatment of acute heart
failure to reduce left ventricular enddiastolic pressure, pulmonary capillary
wedge pressure, peripheral vascular
resistance, and mean arterial blood
pressure.
NIPRIDE RTU (sodium nitroprusside),
10 mg/50 mL (0.2 mg/mL), is currently
listed in the ‘‘Discontinued Drug
Product List’’ section of the Orange
Book.
Cardinal Health Regulatory Sciences
submitted a citizen petition dated July
15, 2020 (Docket No. FDA–2020–P–
1678), under 21 CFR 10.30, requesting
that the Agency determine whether
NIPRIDE RTU (sodium nitroprusside),
10 mg/50 mL (0.2 mg/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 NIPRIDE RTU (sodium
nitroprusside), 10 mg/50 mL (0.2 mg/
mL), was not withdrawn for reasons of
safety or effectiveness. The petitioner
has identified no data or other
E:\FR\FM\16MRN1.SGM
16MRN1
14452
Federal Register / Vol. 86, No. 49 / Tuesday, March 16, 2021 / Notices
information suggesting that NIPRIDE
RTU (sodium nitroprusside), 10 mg/50
mL (0.2 mg/mL), was withdrawn for
reasons of safety or effectiveness. We
have carefully reviewed our files for
records concerning the withdrawal of
NIPRIDE RTU (sodium nitroprusside),
10 mg/50 mL (0.2 mg/mL), 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 NIPRIDE RTU (sodium
nitroprusside), 10 mg/50 mL (0.2 mg/
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. ANDAs that refer
to NIPRIDE RTU (sodium
nitroprusside), 10 mg/50 mL (0.2 mg/
mL), 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: March 9, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–05324 Filed 3–15–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–2347]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Food and
Cosmetic Export Certificate
Application Process
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or we) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (PRA), Federal Agencies are
required to publish notice in the
Federal Register concerning each
proposed collection of information,
jbell on DSKJLSW7X2PROD with NOTICES
SUMMARY:
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16:52 Mar 15, 2021
Jkt 253001
including each proposed extension of an
existing collection of information, and
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on the information
collection provisions associated with
export certificate applications for FDAregulated human food and cosmetic
products.
Submit either electronic or
written comments on the collection of
information by May 17, 2021.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before May 17, 2021.
The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of May 17, 2021. Comments
received by mail/hand delivery/courier
(for written/paper submissions) will be
considered timely if they are
postmarked or the delivery service
acceptance receipt is on or before that
date.
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.
PO 00000
Frm 00050
Fmt 4703
Sfmt 4703
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2014–N–2347 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; Food and
Cosmetic Export Certificate Application
Process.’’ Received comments, those
filed in a timely manner (see
ADDRESSES), will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday
through Friday, 240–402–7500.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852, 240–402–7500.
E:\FR\FM\16MRN1.SGM
16MRN1
]]>Agencies
[Federal Register Volume 86, Number 49 (Tuesday, March 16, 2021)]
[Notices]
[Pages 14451-14452]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-05324]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-P-1678]
Determination That NIPRIDE RTU (Sodium Nitroprusside), 10
Milligrams/50 Milliliters (0.2 Milligrams/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 NIPRIDE RTU (sodium nitroprusside), 10 milligrams (mg)/
50 milliliters (mL) (0.2 mg/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 sodium
nitroprusside, 10 mg/50 mL (0.2 mg/mL), if all other legal and
regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT: Michael Bernstein, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6240, Silver Spring, MD 20993-0002, 301-
796-3478, [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.
NIPRIDE RTU (sodium nitroprusside), 10 mg/50 mL (0.2 mg/mL), is the
subject of NDA 209387, held by Exela Pharma Sciences, LLC, and
initially approved on March 8, 2017. NIPRIDE RTU is indicated for
immediate reduction of blood pressure of adult and pediatric patients
in hypertensive crises; induction and maintenance of controlled
hypotension in adults and children during surgery, to reduce bleeding;
and treatment of acute heart failure to reduce left ventricular end-
diastolic pressure, pulmonary capillary wedge pressure, peripheral
vascular resistance, and mean arterial blood pressure.
NIPRIDE RTU (sodium nitroprusside), 10 mg/50 mL (0.2 mg/mL), is
currently listed in the ``Discontinued Drug Product List'' section of
the Orange Book.
Cardinal Health Regulatory Sciences submitted a citizen petition
dated July 15, 2020 (Docket No. FDA-2020-P-1678), under 21 CFR 10.30,
requesting that the Agency determine whether NIPRIDE RTU (sodium
nitroprusside), 10 mg/50 mL (0.2 mg/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 NIPRIDE RTU (sodium nitroprusside), 10 mg/50
mL (0.2 mg/mL), was not withdrawn for reasons of safety or
effectiveness. The petitioner has identified no data or other
[[Page 14452]]
information suggesting that NIPRIDE RTU (sodium nitroprusside), 10 mg/
50 mL (0.2 mg/mL), was withdrawn for reasons of safety or
effectiveness. We have carefully reviewed our files for records
concerning the withdrawal of NIPRIDE RTU (sodium nitroprusside), 10 mg/
50 mL (0.2 mg/mL), 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 NIPRIDE RTU (sodium
nitroprusside), 10 mg/50 mL (0.2 mg/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. ANDAs that refer to NIPRIDE RTU (sodium nitroprusside),
10 mg/50 mL (0.2 mg/mL), 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: March 9, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-05324 Filed 3-15-21; 8:45 am]
BILLING CODE 4164-01-P
