Determination That ENDEP (Amitriptyline Hydrochloride) Oral Concentrate, 40 Milligrams/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 57202-57203 [2022-20195]
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Federal Register / Vol. 87, No. 180 / Monday, September 19, 2022 / Notices
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lotter on DSK11XQN23PROD with NOTICES1
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A disposition schedule, DAA–0292–
2020–0005, is pending approval by
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the records (background materials for
creation of studies and reports) be cut
17:37 Sep 16, 2022
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VerDate Sep<11>2014
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PO 00000
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HISTORY:
80 FR 17893 (April 2, 2015), 83 FR
6591 (Feb. 14, 2018).
[FR Doc. 2022–20139 Filed 9–16–22; 8:45 am]
BILLING CODE 4184–79–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2022–P–0068]
Determination That ENDEP
(Amitriptyline Hydrochloride) Oral
Concentrate, 40 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Was Not Withdrawn From Sale for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 or Agency) has
determined that ENDEP (amitriptyline
hydrochloride) oral concentrate, 40
milligrams (mg)/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withdrawn from sale for reasons of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 ENDEP
(amitriptyline hydrochloride) oral
concentrate, 40 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,
SUMMARY:
E:\FR\FM\19SEN1.SGM
19SEN1
Federal Register / Vol. 87, No. 180 / Monday, September 19, 2022 / Notices
Silver Spring, MD 20993–0002, 301–
796–1546, Kaetochi.Okemgbo@
fda.hhs.gov.
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.
ENDEP (amitriptyline hydrochloride)
oral concentrate, 40 mg/mL, is the
subject of ANDA 085749, held by
Hoffman-La Roche Inc., and initially
approved on December 23, 1977. ENDEP
(amitriptyline hydrochloride) oral
concentrate, 40 mg/mL, is indicated for
relief of symptoms of depression.
Hoffman-La Roche Inc. has never
marketed ENDEP (amitriptyline
hydrochloride) oral concentrate, 40 mg/
mL. ANDA 085749 is listed in the
‘‘Discontinued Drug Product List’’
section of the Orange Book.
Hyman, Phelps & McNamara, P.C.,
submitted a citizen petition dated
January 11, 2022 (Docket No. FDA–
2022–P–0068), under 21 CFR 10.30,
lotter on DSK11XQN23PROD with NOTICES1
SUPPLEMENTARY INFORMATION:
VerDate Sep<11>2014
17:37 Sep 16, 2022
Jkt 256001
requesting that the Agency determine
whether ENDEP (amitriptyline
hydrochloride) oral concentrate, 40 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 ENDEP (amitriptyline
hydrochloride) oral concentrate, 40 mg/
mL, was not withdrawn for reasons of
safety or effectiveness. The petitioner
has identified no data or other
information suggesting that ENDEP
(amitriptyline hydrochloride) oral
concentrate, 40 mg/mL, was withdrawn
for reasons of safety or effectiveness. We
have carefully reviewed our files for
records concerning the withdrawal of
ENDEP (amitriptyline hydrochloride)
oral concentrate, 40 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 ENDEP (amitriptyline
hydrochloride) oral concentrate, 40 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 ENDEP (amitriptyline hydrochloride)
oral concentrate, 40 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: September 14, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–20195 Filed 9–16–22; 8:45 am]
BILLING CODE 4164–01–P
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57203
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–6395]
Request for Applications for New
Members of the Clinical Trials
Transformation Initiative/Food and
Drug Administration Patient
Engagement Collaborative
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; request for applications.
The Food and Drug
Administration (FDA or Agency), in
collaboration with the Clinical Trials
Transformation Initiative (CTTI), is
requesting applications from patient
advocates interested in participating on
the Patient Engagement Collaborative
(PEC). The PEC is an ongoing,
collaborative forum coordinated through
the Office of Patient Affairs, Office of
Clinical Policy and Programs (OCPP),
Office of the Commissioner at FDA, and
is hosted by CTTI. Through the PEC, the
patient community and regulators are
able to discuss an array of topics
regarding increasing meaningful patient
engagement with diverse populations in
medical product development and
regulatory discussions at FDA. The
activities of the PEC may include, but
are not limited to, providing diverse
perspectives on topics such as
systematic patient engagement,
transparency, and communication;
providing considerations for
implementing new strategies to enhance
patient engagement at FDA; and
proposing new models of collaboration
in which patient and patient advocate
perspectives are incorporated into
general medical product development
and regulatory processes.
DATES: Applications can be submitted
starting at 11:59 p.m. eastern time on
September 19, 2022. This
announcement is open to receive a
maximum of 75 applications.
Applications will be accepted until
11:59 p.m. eastern time on October 19,
2022 or until 75 applications are
received, whichever happens first.
ADDRESSES: All applications should be
submitted to FDA’s Office of Patient
Affairs in OCPP. The preferred
application method is via the online
submission system provided by CTTI,
available at https://duke.qualtrics.com/
jfe/form/SV_5nI1VVWVOaD59ky. For
those applicants unable to submit an
application electronically, please call
FDA’s Office of Patient Affairs at 301–
796–8460 to arrange for mail or delivery
SUMMARY:
E:\FR\FM\19SEN1.SGM
19SEN1
]]>Agencies
[Federal Register Volume 87, Number 180 (Monday, September 19, 2022)]
[Notices]
[Pages 57202-57203]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-20195]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-P-0068]
Determination That ENDEP (Amitriptyline Hydrochloride) Oral
Concentrate, 40 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 or Agency) has
determined that ENDEP (amitriptyline hydrochloride) oral concentrate,
40 milligrams (mg)/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 ENDEP
(amitriptyline hydrochloride) oral concentrate, 40 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,
[[Page 57203]]
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.
ENDEP (amitriptyline hydrochloride) oral concentrate, 40 mg/mL, is
the subject of ANDA 085749, held by Hoffman-La Roche Inc., and
initially approved on December 23, 1977. ENDEP (amitriptyline
hydrochloride) oral concentrate, 40 mg/mL, is indicated for relief of
symptoms of depression.
Hoffman-La Roche Inc. has never marketed ENDEP (amitriptyline
hydrochloride) oral concentrate, 40 mg/mL. ANDA 085749 is listed in the
``Discontinued Drug Product List'' section of the Orange Book.
Hyman, Phelps & McNamara, P.C., submitted a citizen petition dated
January 11, 2022 (Docket No. FDA-2022-P-0068), under 21 CFR 10.30,
requesting that the Agency determine whether ENDEP (amitriptyline
hydrochloride) oral concentrate, 40 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 ENDEP (amitriptyline hydrochloride) oral
concentrate, 40 mg/mL, was not withdrawn for reasons of safety or
effectiveness. The petitioner has identified no data or other
information suggesting that ENDEP (amitriptyline hydrochloride) oral
concentrate, 40 mg/mL, was withdrawn for reasons of safety or
effectiveness. We have carefully reviewed our files for records
concerning the withdrawal of ENDEP (amitriptyline hydrochloride) oral
concentrate, 40 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 ENDEP (amitriptyline
hydrochloride) oral concentrate, 40 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 ENDEP (amitriptyline hydrochloride)
oral concentrate, 40 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: September 14, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-20195 Filed 9-16-22; 8:45 am]
BILLING CODE 4164-01-P
