FDA approves Tretten for Congenital factor XIII deficiency-Novo Nordisk

Novo Nordisk announced the FDA has on 23 December 2013 approved Tretten (Coagulation Factor XIII A-Subunit [Recombinant]) for the routine prophylaxis of bleeding in people with congenital factor XIII (FXIII) A-subunit deficiency. Tretten is the only recombinant treatment for congenital FXIII A-subunit deficiency � a serious, rare bleeding disorder with limited treatment options. Tretten demonstrated safety and efficacy, offering patients once-monthly dosing with a short infusion time.

Treteen is also approved in Canada as Tretten as well as in the EU, Switzerland and Australia as NovoThirteen.