FDA requests additional information from J&J on schizophrenia drug
WASHINGTON The Food and Drug Administration has requested additional data from Johnson & Johnson for determining whether to approve an experimental drug for schizophrenia, J&J announced Tuesday.
The FDA is not requiring new clinical trials for the drug, paliperidone palmitate, but it can’t comment on the contents of the complete response letter it sent to J&J.
The drug uses Ireland-based Elan’s NanoCrystal technology.