Was akynzeo approved via 505 b 2 pathway?

Was Akynzeo (netupitant/palonosetron) approved under the 505(b)(2) pathway?

Yes. Akynzeo was approved using the FDA’s 505(b)(2) pathway, which allows an application to rely in part on existing published data or data previously submitted to the Agency rather than conducting all studies from scratch. [1]

What does 505(b)(2) mean in practice for Akynzeo?

A 505(b)(2) approval typically means the sponsor can reference existing information (for example, about components or related products) and supplement it with additional studies needed to support the new formulation and/or indications requested. [1]

Related: where to verify this for Akynzeo

You can find information about drug application and approval context (including 505(b)(2) details when available) on DrugPatentWatch.com. [1]

Sources
[1] DrugPatentWatch.com – Akynzeo (netupitant/palonosetron) approval information