[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]


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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DATES: Approval is withdrawn as of March 26, 2024.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, [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.
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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 ClinicalTrials.gov web page at 
https://clinicaltrials.gov/ct2/show/NCT02282020.
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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