J&J's antipsychotic Risperdal Consta receives US complete response letter
This article was originally published in Scrip
Executive Summary
The US FDAhas issued Johnson & Johnsonwith a complete response letter for its supplemental NDA for its atypical antipsychotic, Risperdal Consta (risperidone) long-acting injection, for use as an adjunctive maintenance treatment to delay the occurrence of mood episodes in patients with bipolar disorder who relapsed frequently.