FDA announces likely delay on Novo Nordisk diabetes drug

WASHINGTON The Food and Drug Administration has announced that it will be unable to meet the user fee deadline for a timely approval of Novo Nordisk’s drug liragludite.

The FDA will not be able to make an approvability decision until March 23 for the drug, a treatment for Type 2 diabetes. Novo Nordisk had submitted an approval application for the drug on May 23.

The standard review period for FDA action on approval applications is 10 months. Because the agency’s advisory committee meeting will take place shortly before March 23, however, its decision will probably be delayed by a further two months, the company said.