Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
Is Daunorubicin, Cytarabine approved in United States?
Yes. FDA has authorised it.
Who is the marketing authorisation holder for Daunorubicin, Cytarabine in United States?
The First Hospital of Jilin University is the originator. The local marketing authorisation holder may differ — check the official source linked above.