Amphastar Pharmaceuticals, Inc. · 完整回复函 (BLA 761403)

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PN U.S. FOOD & DRUG ADMINISTRATION BLA 761403 COMPLETE RESPONSE Amphastar Pharmaceuticals, Inc. Attention: Magda Albedrop, RAC-Drugs Senior Supervisor of the CMC and Submissions Group Regulatory Affairs 11570 6th Street Rancho Cucamonga, CA 91730 Dear Magda Albedrop: Please refer to your biologics license application (BLA for We also acknowledge receipt of your amendment dated as SP 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 for this action below and, where possible, o

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