Oct 8 (Reuters) - Denmark's Zealand Pharma
said on Tuesday the U.S. Food and Drug Administration (FDA) has
issued a Complete Response Letter (CRL) relating to its drug for
preventing and treating low blood sugar in children with a
genetic disorder.
Zealand is seeking FDA approval for dasiglucagon, which it
plans to use in patients aged seven days or older with
congenital hyperinsulinism (CHI), a genetic disorder in which
the pancreas secretes too much insulin.