AbbVie Inc. · tam yanıt mektubu (BLA 761459)

Kaynak alıntısı

nN U.S. FOOD & DRUG ADMINISTRATION BLA 761459 COMPLETE RESPONSE AbbVie Inc. Attention: Felipe Martins Associate Director, Regulatory Affairs 2525 Dupont Drive Irvine, CA 92612 Dear Felipe Martins: Please refer to your biologics license application (BLA) dated and received April 22, 2025, and your amendments, submitted under an for AGN-151586 for injection. We also acknowledge receipt of your amendment dated April 17, 2026, which was not reviewed for this action. You may incorporate applicable sections of the amendment by specific reference as part of your response to the deficiencies cited in this letter. We have completed our review of this application, as amended, and have determined that we cannot approve this application in its present form. We have described our reasons f

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