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 § 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Approval of NDA 206162 for LYNPARZA (olaparib) Capsules, and all amendments and supplements thereto, is also withdrawn under § 314.150(d) as ( printed page 20987) of March 26, 2024.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)).

89 FR 20986