Sanofi Loses iGlarLixi Advantage Over Novo's iDegLira Amid Pen Problems
Executive Summary
FDA request for more information on pen injector forces three-month review extension, offsetting advantage from priority review voucher redemption.
You may also be interested in...
Novo Nordisk, Sanofi Insulin Combo Products Clear US Regulatory Hurdles
US FDA approves Xultophy and Soliqua, both fixed-ratio combinations of a basal insulin and a GLP-1 agonist, on the same day even though Sanofi redeemed a priority review voucher that earned Soliqua an earlier user fee goal date.
Voucher Does Not Guarantee A Priority Review, FDA Says
Final guidance on the tropical disease priority review voucher program says FDA will adhere to priority review goals, which allow agency to complete some outside the stated time frame.
Pediatric Rare Disease Voucher Program Faces Expiration
Stakeholders push Congress to renew program, although 21st Century Cures route unlikely.