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İş dünyası · 26.03.20241 dk okuma
AstraZeneca Pharmaceuticals LP; Withdrawal of Approval of New Drug Application for LYNPARZA (Olaparib) Capsules
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Özet
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.
Kaynağın orijinal dili: Federal Register — Food and Drug AdministrationOrijinal duyuruyu açın →