Notice2024-06298
AstraZeneca Pharmaceuticals LP; Withdrawal of Approval of New Drug Application for LYNPARZA (Olaparib) Capsules
Primary source
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Published
March 26, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 89 Issue 59 (Tuesday, March 26, 2024)</title>
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[Federal Register Volume 89, Number 59 (Tuesday, March 26, 2024)]
[Notices]
[Pages 20986-20987]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-06298]
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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.
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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DATES: Approval is withdrawn as of March 26, 2024.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, <a href="/cdn-cgi/l/email-protection#3c7755515e594e5045127059544e5a5950587c5a585d1254544f125b534a"><span class="__cf_email__" data-cfemail="8bc0e2e6e9eef9e7f2a5c7eee3f9edeee7efcbedefeaa5e3e3f8a5ece4fd">[email protected]</span></a>.
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.
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\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 <a href="http://ClinicalTrials.gov">ClinicalTrials.gov</a> web page at
<a href="https://clinicaltrials.gov/ct2/show/NCT02282020">https://clinicaltrials.gov/ct2/show/NCT02282020</a>.
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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
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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
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