Novo Nordisk has accepted a fine from Danish regulators over allegations of violating disclosure obligations concerning US rejection of its diabetes drugs Tresiba and Ryzodeq.

A 500,000 kroner fine (just under £53,600) has been imposed by the public prosecutor in a suit filed by the Danish Financial Supervisory Authority. The case stems from Novo’s receipt of a complete response letter from the US Food and Drug Administration for Tresiba (insulin degludec) and Ryzodeg (insulin degludec/insulin aspart) on the evening of Friday February 8 in 2013.

Novo published the FDA’s decision on Sunday 10 February 2013 “following an intensive investigation and evaluation of the implications and impact of the agency’s decision”. However, in the opinion of the FSA and the public prosecutor, the announcement should have been issued on the Friday evening because, even though the market in Denmark was closed, Novo shares could still be traded in the USA.

In February last year, the Nasdaq in Copenhagen launched a similar investigation but declared in May 2013 that it found no basis for concluding Novo had violated the rules, and that it considered the matter closed.

Novo insists that the announcement was issued “in a timely manner [and] was entitled to delay public disclosure until the implications of the decision had been adequately analysed, which they had been on the Sunday”. However, “for resource reasons”, the company’s management has chosen to accept the fine “to avoid a lengthy lawsuit”.

Novo expects to resubmit Tresiba for US approval in mid-2015 as a cardiovascular outcomes trial requested by the FDA is progressing quicker than scheduled. It is already approved in Europe.