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Negocios · 26/3/20241 min de lectura

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

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Resumen

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.

Idioma original de la fuente: Federal Register — Food and Drug AdministrationAbrir el comunicado original →