FDA to review Novo's insulin products, rebuffs rFXIII

Novo Nordisk A/S (CSE:NVO; NYSE:NVO) said FDA accepted for review NDAs for a pair of its insulin products to treat Type I and II diabetes: insulin Degludec and DegludecPlus. The PDUFA date is July 29. Insulin Degludec is a long-acting insulin analog, and DegludecPlus is a combination of 70% insulin Degludec and 30% Novo Nordisk's NovoLog insulin aspart. The products are also under review in Europe.

Novo Nordisk also said Thursday it received a complete response letter from FDA for a BLA for its recombinant factor XIII ( rFXIII) to treat congenital Factor XIII deficiency, a bleeding disorder. Novo Nordisk said FDA asked for additional information, but the pharma did not disclose details. ...