Determination That NUCYNTA (Tapentadol Hydrochloride) Solution, Equivalent 20 Milligrams Base/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 18946-18947 [2024-05582]
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khammond on DSKJM1Z7X2PROD with NOTICES
18946
Federal Register / Vol. 89, No. 52 / Friday, March 15, 2024 / Notices
that DUEXIS (ibuprofen and famotidine)
tablet, 800 mg and 26.6 mg, was being
discontinued, and FDA moved the drug
product to the ‘‘Discontinued Drug
Product List’’ section of the Orange
Book.
Aurobindo Pharma USA, Inc.,
submitted a citizen petition dated
February 14, 2024 (Docket No. FDA–
2024–P–0827), under 21 CFR 10.30,
requesting that the Agency determine
whether DUEXIS (ibuprofen and
famotidine) tablet, 800 mg and 26.6 mg,
was withdrawn from sale for reasons of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 DUEXIS (ibuprofen and
famotidine) tablet, 800 mg and 26.6 mg,
was not withdrawn for reasons of safety
or effectiveness. The petitioner has
identified no data or other information
suggesting that DUEXIS (ibuprofen and
famotidine) tablet, 800 mg and 26.6 mg,
was withdrawn for reasons of safety or
effectiveness. We have carefully
reviewed our files for records
concerning the withdrawal of DUEXIS
(ibuprofen and famotidine) tablet, 800
mg and 26.6 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not withdrawn from sale for reasons of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 DUEXIS (ibuprofen and
famotidine) tablet, 800 mg and 26.6 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. 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: March 12, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–05578 Filed 3–14–24; 8:45 am]
BILLING CODE 4164–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–P–4065]
Determination That NUCYNTA
(Tapentadol Hydrochloride) Solution,
Equivalent 20 Milligrams Base/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 or Agency) has
determined that NUCYNTA (tapentadol
hydrochloride) solution, equivalent (eq)
20 milligrams (mg) base/milliliter (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 tapentadol
hydrochloride solution, eq 20 mg base/
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. 6624,
Silver Spring, MD 20993–0002, 301–
796–1546, Kaetochi.Okemgbo@
fda.hhs.gov.
SUMMARY:
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
SUPPLEMENTARY INFORMATION:
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effectiveness or if FDA determines that
the listed drug was withdrawn from sale
for reasons of safety or effectiveness
§ 314.162 (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.
NUCYNTA (tapentadol
hydrochloride) solution, eq 20 mg base/
mL, is the subject of NDA 203794, held
by Collegium Pharmaceutical, Inc., and
initially approved on October 15, 2012.
NUCYNTA is indicated for the
management of acute pain severe
enough to require an opioid analgesic
and for which alternative treatments are
inadequate in adults and pediatric
patients aged 6 years and older with a
body weight of at least 16 kilograms.
Collegium Pharmaceutical, Inc. has
never marketed NUCYNTA (tapentadol
hydrochloride) solution, eq 20 mg base/
mL. In previous instances (see, e.g., 72
FR 9763, March 5, 2007; 61 FR 25497,
May 21, 1996, the Agency has
determined that, for purposes of
§§ 314.161 and 314.162, never
marketing an approved drug product is
equivalent to withdrawing the drug
from sale.
Novitium Pharma, LLC submitted a
citizen petition dated September 19,
2023 (Docket No. FDA–2023–P–4065),
under 21 CFR 10.30, requesting that the
Agency determine whether NUCYNTA
(tapentadol hydrochloride) solution, eq
20 mg base/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 NUCYNTA (tapentadol
hydrochloride) solution, eq 20 mg base/
mL, was not withdrawn for reasons of
safety or effectiveness. The petitioner
has identified no data or other
information suggesting that NUCYNTA
(tapentadol hydrochloride) solution, eq
20 mg base/mL, was withdrawn for
reasons of safety or effectiveness. We
have carefully reviewed our files for
records concerning the withdrawal of
NUCYNTA (tapentadol hydrochloride)
solution, eq 20 mg base/mL, from sale.
We have also independently evaluated
relevant literature and data for possible
postmarketing adverse events. We have
reviewed the available evidence and
E:\FR\FM\15MRN1.SGM
15MRN1
Federal Register / Vol. 89, No. 52 / Friday, March 15, 2024 / Notices
determined that this drug product was
not withdrawn from sale for reasons of
safety or effectiveness.
Accordingly, the Agency will
continue to list NUCYNTA (tapentadol
hydrochloride) solution, eq 20 mg base/
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 NUCYNTA (tapentadol
hydrochloride) solution, eq 20 mg base/
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 12, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–05582 Filed 3–14–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–D–1774]
Requests for Feedback and Meetings
for Medical Device Submissions: The
Q-Submission Program; Draft
Guidance for Industry and Food and
Drug Administration Staff; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of the draft
guidance entitled ‘‘Requests for
Feedback and Meetings for Medical
Device Submissions: The Q-Submission
Program.’’ This draft guidance
document provides an overview of the
mechanisms available to submitters
through which they can request
interactions with FDA related to
medical device submissions. This draft
guidance, when finalized, is intended to
supersede the document entitled
‘‘Requests for Feedback and Meetings
for Medical Device Submissions: The QSubmission Program’’ issued on June 2,
2023, and provides clarification and
additional information on the scope of
Q-Submission (Q-Sub) types, better
delineation of how to obtain feedback
for different types of questions (i.e.,
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
18:17 Mar 14, 2024
Jkt 262001
informal communication vs. PreSubmission or other Q-Submission
types), and improved examples. This
draft guidance is not final nor is it for
implementation at this time.
DATES: Submit either electronic or
written comments on the draft guidance
by May 14, 2024 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:
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.
• 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–
2018–D–1774 for ‘‘Requests for
Feedback and Meetings for Medical
Device Submissions: The Q-Submission
Program.’’ Received comments will be
placed in the docket and, except for
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18947
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.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
An electronic copy of the guidance
document is available for download
from the internet. See the
SUPPLEMENTARY INFORMATION section for
information on electronic access to the
guidance. Submit written requests for a
single hard copy of the draft guidance
document entitled ‘‘Requests for
Feedback and Meetings for Medical
Device Submissions: The Q-Submission
Program’’ to the Office of Policy, Center
for Devices and Radiological Health,
Food and Drug Administration, 10903
E:\FR\FM\15MRN1.SGM
15MRN1
]]>Agencies
[Federal Register Volume 89, Number 52 (Friday, March 15, 2024)]
[Notices]
[Pages 18946-18947]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-05582]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-P-4065]
Determination That NUCYNTA (Tapentadol Hydrochloride) Solution,
Equivalent 20 Milligrams Base/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 or Agency) has
determined that NUCYNTA (tapentadol hydrochloride) solution, equivalent
(eq) 20 milligrams (mg) base/milliliter (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
tapentadol hydrochloride solution, eq 20 mg base/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. 6624, 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 Sec. 314.162 (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.
NUCYNTA (tapentadol hydrochloride) solution, eq 20 mg base/mL, is
the subject of NDA 203794, held by Collegium Pharmaceutical, Inc., and
initially approved on October 15, 2012. NUCYNTA is indicated for the
management of acute pain severe enough to require an opioid analgesic
and for which alternative treatments are inadequate in adults and
pediatric patients aged 6 years and older with a body weight of at
least 16 kilograms.
Collegium Pharmaceutical, Inc. has never marketed NUCYNTA
(tapentadol hydrochloride) solution, eq 20 mg base/mL. In previous
instances (see, e.g., 72 FR 9763, March 5, 2007; 61 FR 25497, May 21,
1996, the Agency has determined that, for purposes of Sec. Sec.
314.161 and 314.162, never marketing an approved drug product is
equivalent to withdrawing the drug from sale.
Novitium Pharma, LLC submitted a citizen petition dated September
19, 2023 (Docket No. FDA-2023-P-4065), under 21 CFR 10.30, requesting
that the Agency determine whether NUCYNTA (tapentadol hydrochloride)
solution, eq 20 mg base/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 NUCYNTA (tapentadol hydrochloride) solution,
eq 20 mg base/mL, was not withdrawn for reasons of safety or
effectiveness. The petitioner has identified no data or other
information suggesting that NUCYNTA (tapentadol hydrochloride)
solution, eq 20 mg base/mL, was withdrawn for reasons of safety or
effectiveness. We have carefully reviewed our files for records
concerning the withdrawal of NUCYNTA (tapentadol hydrochloride)
solution, eq 20 mg base/mL, from sale. We have also independently
evaluated relevant literature and data for possible postmarketing
adverse events. We have reviewed the available evidence and
[[Page 18947]]
determined that this drug product was not withdrawn from sale for
reasons of safety or effectiveness.
Accordingly, the Agency will continue to list NUCYNTA (tapentadol
hydrochloride) solution, eq 20 mg base/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 NUCYNTA (tapentadol hydrochloride)
solution, eq 20 mg base/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 12, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-05582 Filed 3-14-24; 8:45 am]
BILLING CODE 4164-01-P
