Outlook Therapeutics, Inc. · carta de resposta completa (BLA 761320)

Trecho da fonte

( Lg my U.S. FOOD & DRUG Ny, ADMINISTRATION BLA 761320 COMPLETE RESPONSE Outlook Therapeutics, Inc. Attention: Jennifer Kissner, PhD Senior Vice President, Clinical and Regulatory Affairs 111 South Wood Avenue Unit #100 Iselin, NJ 08830 Dear Dr. Kissner: Please refer to your biologics license application (BLA) oe or bevacizumab-vikg injection. (b) (4) , action letter. We acknowledge receipt of your amendment dated constituted a complete response to our om , which 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, our recommendations to address these issues. There is a lack of substantial evidence consisting of adequate

openFDA