AstraZeneca Pharmaceuticals LP; Withdrawal of Approval of a New Drug Application for IRESSA

摘要

The Food and Drug Administration (FDA) is withdrawing approval of a new drug application (NDA) for IRESSA (gefitinib) Tablets held by AstraZeneca Pharmaceuticals LP (AstraZeneca), 1800 Concord Pike, P.O. Box 8355, Wilmington, DE 19803-8355. AstraZeneca has voluntarily requested that approval of this application be withdrawn, thereby waiving its opportunity for a hearing.