AstraZeneca Pharmaceuticals LP; Withdrawal of Approval of New Drug Application for LYNPARZA (Olaparib) Capsules, 20986-20987 [2024-06298]
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Federal Register / Vol. 89, No. 59 / Tuesday, March 26, 2024 / Notices
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Lauren K. Roth,
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[FR Doc. 2024–06314 Filed 3–25–24; 8:45 am]
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DEPARTMENT OF HEALTH AND
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Food and Drug Administration
[Docket Nos. FDA–2023–N–3168; FDA–
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Title of collection
Extralabel Drug Use in Animals ..............................................................................................................................
Premarket Notification for a New Dietary Ingredient ...............................................................................................
Food and Drug Administration Rapid Response Surveys ......................................................................................
Application for Participation in Food and Drug Administration Fellowship Programs ............................................
Dated: March 20, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–06265 Filed 3–25–24; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–N–1077]
AstraZeneca Pharmaceuticals LP;
Withdrawal of Approval of New Drug
Application for LYNPARZA (Olaparib)
Capsules
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
withdrawing approval of new drug
application (NDA) for LYNPARZA
(olaparib) Capsules, 50 milligrams (mg)
held by AstraZeneca Pharmaceuticals
LP (AZ), 1800 Concord Pike,
Wilmington, DE 19803. AZ has
voluntarily requested that FDA
withdraw approval of this application
ddrumheller on DSK120RN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
18:10 Mar 25, 2024
Jkt 262001
and has waived its opportunity for a
hearing.
DATES: Approval is withdrawn as of
March 26, 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: On
December 19, 2014, FDA approved NDA
206162 for LYNPARZA (olaparib)
Capsules, 50 mg, as monotherapy in
patients with deleterious or suspected
deleterious germline BRCA-mutated (as
detected by an FDA-approved test)
advanced ovarian cancer who have been
treated with three or more prior lines of
chemotherapy. On July 14, 2022, FDA
met with AZ to discuss the final overall
survival (OS) results from the clinical
trial entitled ‘‘A Phase III, Open Label,
Randomised, Controlled, Multi-Centre
Study to Assess the Efficacy and Safety
of Olaparib Monotherapy Versus
Physician’s Choice Single Agent
Chemotherapy in the Treatment of
Platinum Sensitive Relapsed Ovarian
PO 00000
Frm 00047
Fmt 4703
Sfmt 4703
0910–0325
0910–0330
0910–0500
0910–0780
Date approval
expires
2/28/2027
2/28/2027
2/28/2027
2/28/2027
Cancer in Patients Carrying Germline
BRCA1/2 Mutations’’ (SOLO3).’’ 1 The
results indicated that patients who were
taking olaparib potentially had a shorter
OS than patients not on olaparib,
particularly in the subgroup analysis of
patients who had received three or more
lines of chemotherapy. On July 26,
2022, the Agency asked AZ, in writing,
to voluntarily permit FDA to withdraw
approval of NDA 206162, pursuant to
§ 314.150(d) (21 CFR 314.150(d)) and
waive its opportunity for a hearing for
NDA 206162. On January 19, 2023, AZ
submitted a letter requesting withdrawal
of approval of the application for
LYNPARZA (olaparib) Capsules (NDA
206162) pursuant to § 314.150(d) and
waiving its opportunity for a hearing.
Approval of NDA 206162 for
LYNPARZA (olaparib) Capsules, and all
amendments and supplements thereto,
is also withdrawn under § 314.150(d) as
1 The study, under its abbreviated title ‘‘Olaparib
Treatment in Relapsed Germline Breast Cancer
Susceptibility Gene (BRCA) Mutated Ovarian
Cancer Patients Who Have Progressed at Least 6
Months After Last Platinum Treatment and Have
Received at Least 2 Prior Platinum Treatments
(SOLO3),’’ is available on the NIH National Library
of Medicine’s ClinicalTrials.gov web page at https://
clinicaltrials.gov/ct2/show/NCT02282020.
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26MRN1
Federal Register / Vol. 89, No. 59 / Tuesday, March 26, 2024 / Notices
of March 26, 2024. Distribution of
LYNPARZA (olaparib) Capsules, into
interstate commerce without an
approved application is illegal and
subject to regulatory action (see sections
505(a) and 301(d) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C.
355(a) and 331(d)).
Dated: March 15, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–06298 Filed 3–25–24; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–N–1221]
Electronic Submissions: Data
Standards; Support and Requirement
for the Clinical Data Interchange
Standards Consortium Standard for
Exchange of Nonclinical Data
Implementation Guide—Animal Rule
Version 1.0
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration’s (FDA or Agency)
Center for Biologics Evaluation and
Research (CBER) is announcing support
for the Clinical Data Interchange
Standards Consortium (CDISC) Standard
for Exchange of Nonclinical Data
Implementation Guide—Animal Rule
Version 1.0 (SENDIG–AR v1.0) on
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The Agency will update the FDA Data
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ddrumheller on DSK120RN23PROD with NOTICES1
SUMMARY:
ADDRESSES:
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Submit electronic comments in the
following way:
VerDate Sep<11>2014
18:10 Mar 25, 2024
Jkt 262001
• Federal eRulemaking Portal:
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PO 00000
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20987
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E:\FR\FM\26MRN1.SGM
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]]>Agencies
[Federal Register Volume 89, Number 59 (Tuesday, March 26, 2024)]
[Notices]
[Pages 20986-20987]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-06298]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-1077]
AstraZeneca Pharmaceuticals LP; Withdrawal of Approval of New
Drug Application for LYNPARZA (Olaparib) Capsules
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is
withdrawing approval of new drug application (NDA) for LYNPARZA
(olaparib) Capsules, 50 milligrams (mg) held by AstraZeneca
Pharmaceuticals LP (AZ), 1800 Concord Pike, Wilmington, DE 19803. AZ
has voluntarily requested that FDA withdraw approval of this
application and has waived its opportunity for a hearing.
DATES: Approval is withdrawn as of March 26, 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, [email protected].
SUPPLEMENTARY INFORMATION: On December 19, 2014, FDA approved NDA
206162 for LYNPARZA (olaparib) Capsules, 50 mg, as monotherapy in
patients with deleterious or suspected deleterious germline BRCA-
mutated (as detected by an FDA-approved test) advanced ovarian cancer
who have been treated with three or more prior lines of chemotherapy.
On July 14, 2022, FDA met with AZ to discuss the final overall survival
(OS) results from the clinical trial entitled ``A Phase III, Open
Label, Randomised, Controlled, Multi-Centre Study to Assess the
Efficacy and Safety of Olaparib Monotherapy Versus Physician's Choice
Single Agent Chemotherapy in the Treatment of Platinum Sensitive
Relapsed Ovarian Cancer in Patients Carrying Germline BRCA1/2
Mutations'' (SOLO3).'' \1\ The results indicated that patients who were
taking olaparib potentially had a shorter OS than patients not on
olaparib, particularly in the subgroup analysis of patients who had
received three or more lines of chemotherapy. On July 26, 2022, the
Agency asked AZ, in writing, to voluntarily permit FDA to withdraw
approval of NDA 206162, pursuant to Sec. 314.150(d) (21 CFR
314.150(d)) and waive its opportunity for a hearing for NDA 206162. On
January 19, 2023, AZ submitted a letter requesting withdrawal of
approval of the application for LYNPARZA (olaparib) Capsules (NDA
206162) pursuant to Sec. 314.150(d) and waiving its opportunity for a
hearing.
---------------------------------------------------------------------------
\1\ The study, under its abbreviated title ``Olaparib Treatment
in Relapsed Germline Breast Cancer Susceptibility Gene (BRCA)
Mutated Ovarian Cancer Patients Who Have Progressed at Least 6
Months After Last Platinum Treatment and Have Received at Least 2
Prior Platinum Treatments (SOLO3),'' is available on the NIH
National Library of Medicine's ClinicalTrials.gov web page at
https://clinicaltrials.gov/ct2/show/NCT02282020.
---------------------------------------------------------------------------
Approval of NDA 206162 for LYNPARZA (olaparib) Capsules, and all
amendments and supplements thereto, is also withdrawn under Sec.
314.150(d) as
[[Page 20987]]
of March 26, 2024. Distribution of LYNPARZA (olaparib) Capsules, into
interstate commerce without an approved application is illegal and
subject to regulatory action (see sections 505(a) and 301(d) of the
---------------------------------------------------------------------------
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(a) and 331(d)).
Dated: March 15, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-06298 Filed 3-25-24; 8:45 am]
BILLING CODE 4164-01-P
