FDA: Novo’s liraglutide petition needs more review

This past December, Novo Nordisk petitioned the FDA to exclude liraglutide, a GLP-1 agonist used in the company’s Victoza diabetes drug, from the 503B bulks list. Last week, the agency replied with a short interim response saying simply, “FDA has been unable to reach a decision on your petition because it raises complex issues requiring extensive review and analysis by agency officials.”