NVO - FDA Rejects Novo Nordisk's Weekly Insulin Requests Information Related To Manufacturing Process Type 1 Diabetes | Benzinga
On Wednesday, the FDA issued a Complete Response Letter (CRL) related to Novo Nordisk A/S’s (NYSE:NVO) Biologics License Application for once-weekly basal insulin icodec for diabetes mellitus.
In the letter, the FDA has requests related to the manufacturing process and the type 1 diabetes indication before the application review can be completed.
Related: Novo Nordisk’s Once-Weekly Insulin Flagged With Risk Of Low Blood Sugar Ahead Of FDA Review.
Novo Nordisk is evaluating the content of the CRL and ...