Glucagon - 505(b)(2) summary

USFDA approved first ready-to-use Glucagon injectable formulation from Xeris pharma on 10 Sep. 2019. 

Previously approved two other emergency Glucagon products (From Lilly and Novo Nordisk) are lyophilized formulations that require reconstitution with diluent.

Another Glucagon product from Fresenius is also lyophilized powder. Fresenius’ Glucagon was marketed only as diagnostic aid. Recently on 9^th September, Fresenius received USFDA approval to market its Glucagon product for the treatment of hypoglycaemia.

See below comparison on Glucagon injectable products from Lilly, Novo Nordisk and Xeris.

Summary on other 505(b)(2) approvals is available here.

Bortezomib 505(b)(2) approval summary

Fulvestrant 505(b)(2) approval summary

Teriparatide injection (Pfenex) 505(b)(2) approval summary