Determination That JESDUVROQ (daprodustat) Tablets, 1 Milligram, 2 Milligrams, 4 Milligrams, 6 Milligrams, and 8 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 91410 [2024-26915]
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Federal Register / Vol. 89, No. 223 / Tuesday, November 19, 2024 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–P–3482]
Determination That JESDUVROQ
(daprodustat) Tablets, 1 Milligram, 2
Milligrams, 4 Milligrams, 6 Milligrams,
and 8 Milligrams, Were Not Withdrawn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)
has determined that JESDUVROQ
(daprodustat) tablets, 1 milligram (mg),
2 mg, 4 mg, 6 mg, and 8 mg, were not
withdrawn from sale for reasons of
safety or effectiveness. This
determination will allow FDA to
approve abbreviated new drug
applications (ANDAs) for JESDUVROQ
(daprodustat) tablets, 1 mg, 2 mg, 4 mg,
6 mg, and 8 mg, if all other legal and
regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT: Awo
Archampong-Gray, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6243,
Silver Spring, MD 20993–0002, 301–
796–0110, Awo.Archampong-Gray@
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
ddrumheller on DSK120RN23PROD with NOTICES1
SUPPLEMENTARY INFORMATION:
VerDate Sep<11>2014
17:42 Nov 18, 2024
Jkt 265001
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.
JESDUVROQ (daprodustat) tablets, 1
mg, 2 mg, 4 mg, 6 mg, and 8 mg, are the
subject of NDA 216951, held by
GlaxoSmithKline Intellectual Property
(No. 2) Limited England, and initially
approved on February 1, 2023.
JESDUVROQ is a hypoxia-inducible
factor prolyl hydroxylase (HIF PH)
inhibitor indicated for the treatment of
anemia due to chronic kidney disease in
adults who have been receiving dialysis
for at least 4 months. JESDUVROQ
(daprodustat) tablets, 1 mg, 2 mg, 4 mg,
6 mg, and 8 mg, are currently listed in
the ‘‘Discontinued Drug Product List’’
section of the Orange Book.
Qilu Pharmaceutical (Hainan) Co.,
Ltd., submitted a citizen petition dated
July 24, 2024 (Docket No. FDA–2024–P–
3482), under 21 CFR 10.30, requesting
that the Agency determine whether
JESDUVROQ (daprodustat) tablets, 1
mg, 2 mg, 4 mg, 6 mg, and 8 mg, were
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 JESDUVROQ
(daprodustat) tablets, 1 mg, 2 mg, 4 mg,
6 mg, and 8 mg, were not withdrawn for
reasons of safety or effectiveness. The
petitioner has identified no data or other
information suggesting that
JESDUVROQ (daprodustat) tablets, 1
mg, 2 mg, 4 mg, 6 mg, and 8 mg, were
withdrawn for reasons of safety or
effectiveness. We have carefully
reviewed our files for records
concerning the withdrawal of
JESDUVROQ (daprodustat) tablets, 1
mg, 2 mg, 4 mg, 6 mg, and 8 mg, 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 JESDUVROQ
PO 00000
Frm 00098
Fmt 4703
Sfmt 4703
(daprodustat) tablets, 1 mg, 2 mg, 4 mg,
6 mg, and 8 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.
ANDAs that refer to JESDUVROQ
(daprodustat) tablets, 1 mg, 2 mg, 4 mg,
6 mg, or 8 mg, 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: November 7, 2024.
Kimberlee Trzeciak,
Deputy Commissioner for Policy, Legislation,
and International Affairs.
[FR Doc. 2024–26915 Filed 11–18–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–N–4860]
Pfizer, Inc., et al.; Withdrawal of
Approval of 26 New Drug Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
withdrawing approval of 26 new drug
applications (NDAs) from multiple
applicants. The applicants notified the
Agency in writing that the drug
products were no longer marketed and
requested that the approval of the
applications be withdrawn.
DATES: Approval is withdrawn as of
December 19, 2024.
FOR FURTHER INFORMATION CONTACT:
Kimberly Lehrfeld, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6226,
Silver Spring, MD 20993–0002, 301–
796–3137, Kimberly.Lehrfeld@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: The
applicants listed in table 1 have
informed FDA that these drug products
are no longer marketed and have
requested that FDA withdraw approval
of the applications under the process in
§ 314.150(c) (21 CFR 314.150(c)). The
applicants have also, by their requests,
waived their opportunity for a hearing.
SUMMARY:
E:\FR\FM\19NON1.SGM
19NON1
]]>Agencies
[Federal Register Volume 89, Number 223 (Tuesday, November 19, 2024)]
[Notices]
[Page 91410]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-26915]
[[Page 91410]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-P-3482]
Determination That JESDUVROQ (daprodustat) Tablets, 1 Milligram,
2 Milligrams, 4 Milligrams, 6 Milligrams, and 8 Milligrams, Were 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) has
determined that JESDUVROQ (daprodustat) tablets, 1 milligram (mg), 2
mg, 4 mg, 6 mg, and 8 mg, were not withdrawn from sale for reasons of
safety or effectiveness. This determination will allow FDA to approve
abbreviated new drug applications (ANDAs) for JESDUVROQ (daprodustat)
tablets, 1 mg, 2 mg, 4 mg, 6 mg, and 8 mg, if all other legal and
regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT: Awo Archampong-Gray, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6243, Silver Spring, MD 20993-0002, 301-
796-0110, [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.
JESDUVROQ (daprodustat) tablets, 1 mg, 2 mg, 4 mg, 6 mg, and 8 mg,
are the subject of NDA 216951, held by GlaxoSmithKline Intellectual
Property (No. 2) Limited England, and initially approved on February 1,
2023. JESDUVROQ is a hypoxia-inducible factor prolyl hydroxylase (HIF
PH) inhibitor indicated for the treatment of anemia due to chronic
kidney disease in adults who have been receiving dialysis for at least
4 months. JESDUVROQ (daprodustat) tablets, 1 mg, 2 mg, 4 mg, 6 mg, and
8 mg, are currently listed in the ``Discontinued Drug Product List''
section of the Orange Book.
Qilu Pharmaceutical (Hainan) Co., Ltd., submitted a citizen
petition dated July 24, 2024 (Docket No. FDA-2024-P-3482), under 21 CFR
10.30, requesting that the Agency determine whether JESDUVROQ
(daprodustat) tablets, 1 mg, 2 mg, 4 mg, 6 mg, and 8 mg, were 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 JESDUVROQ (daprodustat) tablets, 1 mg, 2 mg, 4
mg, 6 mg, and 8 mg, were not withdrawn for reasons of safety or
effectiveness. The petitioner has identified no data or other
information suggesting that JESDUVROQ (daprodustat) tablets, 1 mg, 2
mg, 4 mg, 6 mg, and 8 mg, were withdrawn for reasons of safety or
effectiveness. We have carefully reviewed our files for records
concerning the withdrawal of JESDUVROQ (daprodustat) tablets, 1 mg, 2
mg, 4 mg, 6 mg, and 8 mg, 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 JESDUVROQ
(daprodustat) tablets, 1 mg, 2 mg, 4 mg, 6 mg, and 8 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. ANDAs that refer to JESDUVROQ
(daprodustat) tablets, 1 mg, 2 mg, 4 mg, 6 mg, or 8 mg, 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: November 7, 2024.
Kimberlee Trzeciak,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2024-26915 Filed 11-18-24; 8:45 am]
BILLING CODE 4164-01-P
