- Novo Nordisk has been fined by Danish regulators over allegations that the company violated disclosure obligations related to the FDA’s rejection of diabetes treatments Tresiba (insulin degludec) and Ryzodeq (insuin degludec/insulin aspart).
- A public prosecutor in Denmark imposed the $89,000 fine due to Novo's handling of a Complete Response Letter (CRL) from the FDA that the company received on the evening of February 8, 2013. Novo waited until February 10 to announce the rejection.
- Although Novo has accepted the fine, it contends that the announcement was “issued in a timely manner.”
The Danish Financial Supervising Authority's main complaint was that, although the market was closed in Denmark when the FDA decision was first made available, Novo shares could have still been traded in the US at the time.
Novo insists that the two-day delay allowed the company to comprehensively assess the CRL's implications. Regardless, the fine has now been paid and Novo is looking to resubmit Tresiba for approval in the US in mid-2015.