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Liraglutide Generics May Need More Robust Analytical Methods After Novo Petition

 
• By Michael Cipriano

ANDA pathway is not sufficient to review liraglutide generics because of molecule's complexity, Novo contends; Teva appears to be first filer for Victoza.

Sponsors developing generics of Novo Nordisk AS's various liraglutide drugs might need to rely on robust analytics to get an approval for an abbreviated new drug application (ANDA), as a Novo citizen petition claims currently available analytical methods are insufficient to demonstrate bioequivalence.

In a petition dated Oct. 2, the Danish drugmaker requested the US FDA refrain from approving ANDAs that list...

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• By Dean Rudge

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