Dr. Reddy's Laboratories, Inc.; Withdrawal of Approval of 11 Abbreviated New Drug Applications, 68628-68629 [2023-21992]
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lotter on DSK11XQN23PROD with NOTICES1
68628
Federal Register / Vol. 88, No. 191 / Wednesday, October 4, 2023 / Notices
teleconferencing and/or video
conferencing platform.
The Committee will receive updates
on the accelerated approval program in
oncology and two new drug
applications (NDAs) approved under 21
CFR 314.500 (subpart H, accelerated
approval regulations) that have not met
their agreed-upon milestones for
completion of confirmatory trial(s).
Confirmatory trials are postmarketing
studies to verify and describe the
clinical benefit of a drug after it receives
accelerated approval. These updates
will provide information on the status of
all accelerated approvals granted in
oncology, including products with
delayed confirmatory trials, and the
status of confirmatory trials for the
specific NDAs to be discussed,
including any ongoing and planned
trials.
The two products to be discussed are:
(1) FOLOTYN (pralatrexate), NDA
022468 submitted by Acrotech
Biopharma Inc, indicated for the
treatment of patients with relapsed or
refractory peripheral T-cell lymphoma
(PTCL), and (2) BELEODAQ (belinostat),
NDA 206256 submitted by Acrotech
Biopharma Inc, indicated for the
treatment of patients with relapsed or
refractory PTCL. Based on the updates
provided, the Committee will have a
general discussion about delayed
confirmatory trials as well as a focused
discussion on next steps for the two
products, FOLOTYN (pralatrexate) and
BELEODAQ (belinostat), approved for
PTCL. The overall goal will be the
continued optimization of the
accelerated approval process with a
focus on decreasing the amount of time
to verify (or fail to verify) clinical
benefit, while continuing to provide
early availability of promising oncology
products.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its website prior to the
meeting, the background material will
be made publicly available on FDA’s
website at the time of the advisory
committee meeting. Background
material and the link to the online
teleconference and/or video conference
meeting will be available at https://
www.fda.gov/AdvisoryCommittees/
Calendar/default.htm. Scroll down to
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The meeting will include slide
presentations with audio and video
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components to allow the presentation of
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Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the Committee. All electronic and
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ADDRESSES) on or before November 1,
2023, will be provided to the
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request to speak by October 25, 2023.
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meetings and will make every effort to
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CONTACT) at least 7 days in advance of
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htm for procedures on public conduct
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Notice of this meeting is given under
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also serves as notice that, pursuant to 21
CFR 10.19, the requirements in 21 CFR
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location of advisory committee meetings
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meeting to take place using an online
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interest of allowing greater transparency
and opportunities for public
participation, in addition to
convenience for advisory committee
members, speakers, and guest speakers.
No participant will be prejudiced by
this waiver, and the ends of justice will
be served by allowing for this
modification to FDA’s advisory
committee meeting procedures.
Dated: September 29, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–21984 Filed 10–3–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–3859]
Dr. Reddy’s Laboratories, Inc.;
Withdrawal of Approval of 11
Abbreviated New Drug Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) is
withdrawing approval of 11 abbreviated
new drug applications (ANDAs) from
Dr. Reddy’s Laboratories, Inc. The
applicant notified the Agency in writing
that the drug products were no longer
marketed and requested that the
approval of the applications be
withdrawn.
SUMMARY:
Approval is withdrawn as of
November 3, 2023.
FOR FURTHER INFORMATION CONTACT:
Martha Nguyen, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1676,
Silver Spring, MD 20993–0002, 240–
402–6980, Martha.Nguyen@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: The
applicant listed in the table has
informed FDA that these drug products
are no longer marketed and has
requested that FDA withdraw approval
of the applications under the process
described in § 314.150(c) (21 CFR
314.150(c)). The applicant has also, by
their request, waived the opportunity
for a hearing. Withdrawal of approval of
an application or abbreviated
application under § 314.150(c) is
without prejudice to refiling.
DATES:
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Federal Register / Vol. 88, No. 191 / Wednesday, October 4, 2023 / Notices
Application No.
Drug
ANDA 090177 .......
Oxycodone and Acetaminophen Tablets, 3.25 milligrams
(mg); 2.5 mg, 325 mg; 5 mg, 325 mg; 7.5 mg, 325 mg; 10
mg, 500 mg; 7.5 mg, 650 mg; 10 mg.
Oxycodone Hydrochloride (HCl) Tablets, 5 mg, 10 mg, 15
mg, 20 mg, 30 mg.
Oxycodone and Aspirin Tablets, 325 mg; 4.8355 mg ............
Oxycodone HCl Capsules, 5 mg ............................................
Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, 325 mg; 50 mg; 40 mg; 30 mg.
Clozapine Tablets, 25 mg, 50 mg, 100 mg, 200 mg ..............
Oxycodone HCl Oral Solution 100 mg/5 milliliters .................
Morphine Sulfate Extended-Release Tablets, 15 mg, 30 mg,
60 mg, 100 mg.
Fentanyl Citrate Tablets, Equivalent to (EQ) 0.1 mg base,
EQ 0.2 mg base, EQ 0.3 mg base, EQ 0.4 mg base, EQ
0.6 mg base, EQ 0.8 mg base.
Buprenorphine HCl and Naloxone HCI Tablets, EQ 2 mg
base, EQ 0.5 mg base; EQ 8 mg base, EQ 2 mg base.
Morphine Sulfate Tablets, 15 mg, 30 mg ...............................
ANDA 091313 .......
ANDA 091670 .......
ANDA 203107 .......
ANDA 203335 .......
ANDA 203807 .......
ANDA 204092 .......
ANDA 205386 .......
ANDA 206329 .......
ANDA 206953 .......
ANDA 207270 .......
Therefore, approval of the
applications listed in the table, and all
amendments and supplements thereto,
is hereby withdrawn as of November 3,
2023. Approval of each entire
application is withdrawn, including any
strengths and dosage forms
inadvertently missing from the table.
Introduction or delivery for introduction
into interstate commerce of products
without approved new drug
applications violates section 301(a) and
(d) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 331(a) and (d)).
Drug products that are listed in the table
that are in inventory on November 3,
2023 may continue to be dispensed
until the inventories have been depleted
or the drug products have reached their
expiration dates or otherwise become
violative, whichever occurs first.
Dated: September 29, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–21992 Filed 10–3–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Announcement of the President’s
Advisory Commission on Asian
Americans, Native Hawaiians, and
Pacific Islanders Meeting and
Solicitation for Written Comments
Department of Health and
Human Services, Office of the Secretary,
Office of Intergovernmental and
External Affairs, White House Initiative
on Asian Americans, Native Hawaiians,
and Pacific Islanders.
lotter on DSK11XQN23PROD with NOTICES1
AGENCY:
Notice of meeting and
solicitation for written comments.
ACTION:
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Applicant
Dr. Reddy’s Laboratories, Inc., U.S. Agent for Dr. Reddy’s
Laboratories SA, 107 College Rd. East, Princeton NJ
08540.
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The U.S. Department of
Health and Human Services (HHS)
announces the next meeting of the
President’s Advisory Commission on
Asian Americans, Native Hawaiians,
and Pacific Islanders (Commission) and
the solicitation of written comments
regarding the advancement of equity,
justice, and opportunity for Asian
American, Native Hawaiian, and Pacific
Islander (AA and NHPI) communities.
The meeting is open to the public and
will be held in Washington, DC on
October 25 and October 26, 2023.
Virtual attendance will be available
through livestream. The Commission is
working to accomplish its mission to
provide independent advice and
recommendations to the President on
ways to advance equity, justice, and
opportunity for AA and NHPI
communities.
DATES: The Commission will meet on
October 25, 2023, from 9:00 a.m. Eastern
Time (ET) to 4:30 p.m. ET and October
26, 2023, from 9:00 a.m. ET to 2:00 p.m.
ET. The final location and agenda will
be posted on the website for the
President’s Advisory Commission on
Asian Americans, Native Hawaiians,
and Pacific Islanders: https://
www.hhs.gov/about/whiaanhpi/
commission/ when this
information becomes available.
ADDRESSES: Members of the public may
attend virtually. Registration is required
through the following link: https://
www.eventbrite.com/e/meeting-of-thepresidents-advisory-commission-on-aaand-nhpis-tickets-715434733547?aff=
oddtdtcreator.
FOR FURTHER INFORMATION CONTACT:
Viviane Chao, Designated Federal
Officer, President’s Advisory
Commission on Asian Americans,
Native Hawaiians, and Pacific Islanders,
SUMMARY:
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U.S. Department of Health and Human
Services, Office of the Secretary, Office
of Intergovernmental and External
Affairs, Hubert H. Humphrey Building,
Room 620E, 200 Independence Ave.
SW, Washington, DC 20201; email:
AANHPICommission@hhs.gov;
telephone: (202) 690–6060.
SUPPLEMENTARY INFORMATION: The
meeting is the seventh in a series of
Federal advisory committee meetings
regarding the development of
recommendations to advance equity,
justice, and opportunity for AA and
NHPI communities. The meeting is open
to the public and will be live streamed.
The Commission, co-chaired by HHS
Secretary Xavier Becerra and the U.S.
Trade Representative Ambassador
Katherine Tai, advises the President on:
the development, monitoring, and
coordination of executive branch efforts
to advance equity, justice, and
opportunity for AA and NHPI
communities in the United States,
including efforts to close gaps in health,
socioeconomic, employment, and
educational outcomes; policies to
address and end anti-Asian bias,
xenophobia, racism, and nativism, and
opportunities for the executive branch
to advance inclusion, belonging, and
public awareness of the diversity and
accomplishments of AA and NHPI
people, cultures, and histories; policies,
programs, and initiatives to prevent,
report, respond to, and track anti-Asian
hate crimes and hate incidents; ways in
which the Federal Government can
build on the capacity and contributions
of AA and NHPI communities through
equitable Federal funding, grantmaking,
and employment opportunities; policies
and practices to improve research and
equitable data disaggregation regarding
AA and NHPI communities; policies
and practices to improve language
E:\FR\FM\04OCN1.SGM
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]]>Agencies
[Federal Register Volume 88, Number 191 (Wednesday, October 4, 2023)]
[Notices]
[Pages 68628-68629]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-21992]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-3859]
Dr. Reddy's Laboratories, Inc.; Withdrawal of Approval of 11
Abbreviated New Drug Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or the Agency) is
withdrawing approval of 11 abbreviated new drug applications (ANDAs)
from Dr. Reddy's Laboratories, Inc. The applicant 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 November 3, 2023.
FOR FURTHER INFORMATION CONTACT: Martha Nguyen, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1676, Silver Spring, MD 20993-0002, 240-
402-6980, [email protected].
SUPPLEMENTARY INFORMATION: The applicant listed in the table has
informed FDA that these drug products are no longer marketed and has
requested that FDA withdraw approval of the applications under the
process described in Sec. 314.150(c) (21 CFR 314.150(c)). The
applicant has also, by their request, waived the opportunity for a
hearing. Withdrawal of approval of an application or abbreviated
application under Sec. 314.150(c) is without prejudice to refiling.
[[Page 68629]]
------------------------------------------------------------------------
Application No. Drug Applicant
------------------------------------------------------------------------
ANDA 090177................. Oxycodone and Dr. Reddy's
Acetaminophen Laboratories, Inc.,
Tablets, 3.25 U.S. Agent for Dr.
milligrams (mg); Reddy's
2.5 mg, 325 mg; 5 Laboratories SA,
mg, 325 mg; 7.5 mg, 107 College Rd.
325 mg; 10 mg, 500 East, Princeton NJ
mg; 7.5 mg, 650 mg; 08540.
10 mg.
ANDA 091313................. Oxycodone Do.
Hydrochloride (HCl)
Tablets, 5 mg, 10
mg, 15 mg, 20 mg,
30 mg.
ANDA 091670................. Oxycodone and Do.
Aspirin Tablets,
325 mg; 4.8355 mg.
ANDA 203107................. Oxycodone HCl Do.
Capsules, 5 mg.
ANDA 203335................. Butalbital, Aspirin, Do.
Caffeine, and
Codeine Phosphate
Capsules, 325 mg;
50 mg; 40 mg; 30 mg.
ANDA 203807................. Clozapine Tablets, Do.
25 mg, 50 mg, 100
mg, 200 mg.
ANDA 204092................. Oxycodone HCl Oral Do.
Solution 100 mg/5
milliliters.
ANDA 205386................. Morphine Sulfate Do.
Extended-Release
Tablets, 15 mg, 30
mg, 60 mg, 100 mg.
ANDA 206329................. Fentanyl Citrate Do.
Tablets, Equivalent
to (EQ) 0.1 mg
base, EQ 0.2 mg
base, EQ 0.3 mg
base, EQ 0.4 mg
base, EQ 0.6 mg
base, EQ 0.8 mg
base.
ANDA 206953................. Buprenorphine HCl Do.
and Naloxone HCI
Tablets, EQ 2 mg
base, EQ 0.5 mg
base; EQ 8 mg base,
EQ 2 mg base.
ANDA 207270................. Morphine Sulfate Do.
Tablets, 15 mg, 30
mg.
------------------------------------------------------------------------
Therefore, approval of the applications listed in the table, and
all amendments and supplements thereto, is hereby withdrawn as of
November 3, 2023. Approval of each entire application is withdrawn,
including any strengths and dosage forms inadvertently missing from the
table. Introduction or delivery for introduction into interstate
commerce of products without approved new drug applications violates
section 301(a) and (d) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 331(a) and (d)). Drug products that are listed in the table that
are in inventory on November 3, 2023 may continue to be dispensed until
the inventories have been depleted or the drug products have reached
their expiration dates or otherwise become violative, whichever occurs
first.
Dated: September 29, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-21992 Filed 10-3-23; 8:45 am]
BILLING CODE 4164-01-P
