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FEDERAL REGISTER · NOTICEMarch 26, 2024

AstraZeneca Pharmaceuticals LP; Withdrawal of Approval of New Drug Application for LYNPARZA (Olaparib) Capsules

Document type
Notice
Agency
Health and Human Services Department
Published
March 26, 2024
Document number
2024-06298
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.

Abstract as published in the Federal Register.

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Document details are published in the U.S. Federal Register; SPEQ surfaces them for reference and is not affiliated with or endorsed by the FDA or the Office of the Federal Register. The authoritative text is on federalregister.gov.