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 Nifekalant hydrochloride approved in United States?
Yes. FDA has authorised it.
Who is the marketing authorisation holder for Nifekalant hydrochloride in United States?
Sichuan Baili Pharmaceutical Co., Ltd. is the originator. The local marketing authorisation holder may differ — check the official source linked above.