FDA Won’t Raise the Bar for Drugs Referencing Novo Nordisk
The FDA turned down a request from Novo Nordisk to deny ANDAs referencing its liraglutide-containing drugs without comparative studies.
In an October citizen petition, the drug company asked the agency not to approve abbreviated 505(b)(2) NDAs referencing its liraglutide products without clinical comparative studies indicating the candidate has a similar safety and efficacy profile, and not to approve ANDAs referencing those drugs at all.
It also called on the agency to issue guidance establishing standards for assessing whether follow-on liraglutide products are sufficiently similar to Novo Nordisk’s to rely on the existing safety and efficacy profile.
The petition cited the company’s own analytical comparisons of its liraglutide drug substance with copies from unidentified suppliers, saying it found impurity profiles that differed from its own.