Determination That OFIRMEV (Acetaminophen) Injection, 1,000 Milligrams/100 Milliliters (10 Milligrams/Milliliter), Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 2934-2935 [2023-00792]
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2934
Federal Register / Vol. 88, No. 11 / Wednesday, January 18, 2023 / Notices
lotter on DSK11XQN23PROD with NOTICES1
as a manufacturing process. Please note
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Submit written/paper submissions as
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• Mail/Hand Delivery/Courier (for
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• 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–
2022–N–3299 for ‘‘Understanding the
Use of Negative Controls to Assess the
Validity of Non-Interventional Studies
of Treatment Using Real-World
Evidence.’’ Received comments, those
filed in a timely manner, will be placed
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Submissions,’’ publicly viewable at
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VerDate Sep<11>2014
17:41 Jan 17, 2023
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must identify this information as
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more information about FDA’s posting
of comments to public dockets, see 80
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and/or go to the Dockets Management
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FOR FURTHER INFORMATION CONTACT:
Jamila Mwidau, Food and Drug
Administration, Center for Drug
Evaluation and Research, 10903 New
Hampshire Ave., Bldg. 22, Rm. 4481,
Silver Spring, MD 20993, 301–796–
4989, Jamila.Mwidau@fda.hhs.gov; or
Stephen Ripley, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993, 240–402–
7911.
SUPPLEMENTARY INFORMATION:
I. Background
In connection with the seventh
iteration of the Prescription Drug User
Fee Amendments (PDUFA VII),
incorporated as part of the FDA User
Fee Reauthorization Act of 2022, FDA
has committed to enhancing and
modernizing the FDA drug safety
system, including improving the utility
of existing tools and adopting new
scientific approaches. This commitment
includes optimizing the capabilities of
the Sentinel Initiative to address
questions of product safety and advance
the understanding of how Real-World
Evidence can be used for studying
effectiveness.
Under PDUFA VII, FDA agreed to
conduct a public workshop by
September 30, 2023, on the use of
negative controls for assessing the
validity of non-interventional studies of
treatment. This public workshop,
scheduled for March 8, 2023, will
satisfy the PDUFA VII commitment. One
purpose of the public workshop is to
discuss current negative control
methods in studies based on real-world
data and discuss future implications for
their use to evaluate the safety of
regulated medical products. Another
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purpose of the public workshop is to
present the proposed methods
development projects that may support
a tool for use in the Sentinel System and
BEST.
II. Topics for Discussion at the Public
Workshop
Some topics FDA plans to discuss at
the public workshop include but may
not be limited to the following:
1. What are the strengths and
limitations of current negative control
methods used in studies based on realworld data?
2. What are known and potential
benefits and challenges in using
negative controls in evaluating regulated
product safety and effectiveness?
3. What additional information is
needed about negative control methods
to provide confidence regarding their
use in regulatory decision-making?
III. Participating in the Public
Workshop
Registration: To register for the public
workshop, please visit the following
website to register: https://duke.is/
cy9w4. Please provide complete contact
information for each attendee, including
name, title, affiliation, address, email,
and telephone.
Registration is free and open until the
public workshop is completed. Persons
interested in attending this public
workshop can register until 2:59 p.m.
Eastern Standard Time on March 8,
2023.
If you need special accommodations
due to a disability, please contact
margolisevents@duke.edu no later than
February 22, 2023.
Dated: January 12, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–00840 Filed 1–17–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2022–P–1982]
Determination That OFIRMEV
(Acetaminophen) Injection, 1,000
Milligrams/100 Milliliters (10
Milligrams/Milliliter), 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, Agency, or we)
SUMMARY:
E:\FR\FM\18JAN1.SGM
18JAN1
lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 88, No. 11 / Wednesday, January 18, 2023 / Notices
has determined that OFIRMEV
(acetaminophen) injection, 1,000
milligrams (mg)/100 milliliters (mL) (10
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
acetaminophen injection, 1,000 mg/100
mL (10 mg/mL), if all other legal and
regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT:
Kaetochi Okemgbo, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6224,
Silver Spring, MD 20993–0002, 301–
796–1546, Kaetochi.Okemgbo@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Section
505(j) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C.
355(j)) allows the submission of an
ANDA to market a generic version of a
previously approved drug product. To
obtain approval, the ANDA applicant
must show, among other things, that the
generic drug product: (1) has the same
active ingredient(s), dosage form, route
of administration, strength, conditions
of use, and (with certain exceptions)
labeling as the listed drug, which is a
version of the drug that was previously
approved, and (2) is bioequivalent to the
listed drug. ANDA applicants do not
have to repeat the extensive clinical
testing otherwise necessary to gain
approval of a new drug application
(NDA).
Section 505(j)(7) of the FD&C Act
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.
OFIRMEV (acetaminophen) injection,
1,000 mg/100 mL (10 mg/mL), is the
VerDate Sep<11>2014
17:41 Jan 17, 2023
Jkt 259001
subject of NDA 022450, held by
Mallinckrodt Hospital Products IP Ltd.
(Mallinckrodt), and initially approved
on November 2, 2010. OFIRMEV is
indicated for management of mild to
moderate pain in adult and pediatric
patients 2 years and older, management
of moderate to severe pain with
adjunctive opioid analgesics in adult
and pediatric patients 2 years and older,
and reduction of fever in adult and
pediatric patients.
In a letter dated June 24, 2021,
Mallinckrodt notified FDA that
OFIRMEV (acetaminophen) injection,
1,000 mg/100 mL (10 mg/mL), was
being discontinued, and FDA moved the
drug product to the ‘‘Discontinued Drug
Product List’’ section of the Orange
Book.
Nines Consult Pharma, LLC,
submitted a citizen petition dated
August 22, 2022 (Docket No. FDA–
2022–P–1982), under 21 CFR 10.30,
requesting that the Agency determine
whether OFIRMEV (acetaminophen)
injection, 1,000 mg/100 mL (10 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 OFIRMEV
(acetaminophen) injection, 1,000 mg/
100 mL (10 mg/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 OFIRMEV
(acetaminophen) injection, 1,000 mg/
100 mL (10 mg/mL), 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 OFIRMEV
(acetaminophen) injection, 1,000 mg/
100 mL (10 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 OFIRMEV (acetaminophen) injection,
1,000 mg/100 mL (10 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
PO 00000
Frm 00059
Fmt 4703
Sfmt 4703
2935
for this drug product should be revised
to meet current standards, the Agency
will advise ANDA applicants to submit
such labeling.
Dated: January 10, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–00792 Filed 1–17–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2022–N–1600]
Gabriel J. Letizia, Jr.: Final Debarment
Order
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is issuing an
order under the Federal Food, Drug, and
Cosmetic Act (FD&C Act) permanently
debarring Gabriel J. Letizia, Jr. from
providing services in any capacity to a
person that has an approved or pending
drug product application. FDA bases
this order on a finding that Mr. Letizia
was convicted of a felony under Federal
law for conduct that relates to the
regulation of a drug product under the
FD&C Act. Mr. Letizia was given notice
of the proposed permanent debarment
and was given an opportunity to request
a hearing to show why he should not be
debarred within the timeframe
prescribed by regulation. Mr. Letizia has
not responded to the notice. Mr.
Letizia’s failure to respond and request
a hearing within the prescribed
timeframe constitutes a waiver of his
right to a hearing concerning this action.
DATES: This order is applicable January
18, 2023.
ADDRESSES: Submit applications for
special termination of debarment to the
Dockets Management Staff, Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852,
240–402–7500, or at https://
www.regulations.gov.
FOR FURTHER INFORMATION CONTACT:
Jaime Espinosa, Division of Compliance
and Enforcement, Office of Policy,
Compliance, and Enforcement, Office of
Regulatory Affairs, Food and Drug
Administration, 240–402–8743, or at
debarments@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. Background
Section 306(a)(2)(B) of the FD&C Act
(21 U.S.C. 335a(a)(2)(B)) requires
E:\FR\FM\18JAN1.SGM
18JAN1
]]>Agencies
[Federal Register Volume 88, Number 11 (Wednesday, January 18, 2023)]
[Notices]
[Pages 2934-2935]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-00792]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-P-1982]
Determination That OFIRMEV (Acetaminophen) Injection, 1,000
Milligrams/100 Milliliters (10 Milligrams/Milliliter), 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, Agency, or we)
[[Page 2935]]
has determined that OFIRMEV (acetaminophen) injection, 1,000 milligrams
(mg)/100 milliliters (mL) (10 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 acetaminophen
injection, 1,000 mg/100 mL (10 mg/mL), if all other legal and
regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT: Kaetochi Okemgbo, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6224, Silver Spring, MD 20993-0002, 301-
796-1546, [email protected].
SUPPLEMENTARY INFORMATION: Section 505(j) of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)) allows the submission of
an ANDA to market a generic version of a previously approved drug
product. To obtain approval, the ANDA applicant must show, among other
things, that the generic drug product: (1) has the same active
ingredient(s), dosage form, route of administration, strength,
conditions of use, and (with certain exceptions) labeling as the listed
drug, which is a version of the drug that was previously approved, and
(2) is bioequivalent to the listed drug. ANDA applicants do not have to
repeat the extensive clinical testing otherwise necessary to gain
approval of a new drug application (NDA).
Section 505(j)(7) of the FD&C Act 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.
OFIRMEV (acetaminophen) injection, 1,000 mg/100 mL (10 mg/mL), is
the subject of NDA 022450, held by Mallinckrodt Hospital Products IP
Ltd. (Mallinckrodt), and initially approved on November 2, 2010.
OFIRMEV is indicated for management of mild to moderate pain in adult
and pediatric patients 2 years and older, management of moderate to
severe pain with adjunctive opioid analgesics in adult and pediatric
patients 2 years and older, and reduction of fever in adult and
pediatric patients.
In a letter dated June 24, 2021, Mallinckrodt notified FDA that
OFIRMEV (acetaminophen) injection, 1,000 mg/100 mL (10 mg/mL), was
being discontinued, and FDA moved the drug product to the
``Discontinued Drug Product List'' section of the Orange Book.
Nines Consult Pharma, LLC, submitted a citizen petition dated
August 22, 2022 (Docket No. FDA-2022-P-1982), under 21 CFR 10.30,
requesting that the Agency determine whether OFIRMEV (acetaminophen)
injection, 1,000 mg/100 mL (10 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 OFIRMEV (acetaminophen) injection, 1,000 mg/
100 mL (10 mg/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 OFIRMEV (acetaminophen) injection,
1,000 mg/100 mL (10 mg/mL), 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 OFIRMEV
(acetaminophen) injection, 1,000 mg/100 mL (10 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 OFIRMEV
(acetaminophen) injection, 1,000 mg/100 mL (10 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: January 10, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-00792 Filed 1-17-23; 8:45 am]
BILLING CODE 4164-01-P
