Health
Novo’s Weekly Insulin Denied Approval as FDA Requests More Information
- Agency requires further details on type 1 diabetes indication
- Novo doesn’t expect to fulfill the FDA requests this year
Novo Nordisk A/S’s once-weekly insulin failed to get approval from US regulators Wednesday after the government asked for more information in order to complete its review.
The company said the US Food and Drug Administration asked for details on the manufacturing process and the type 1 diabetes indication.