This article was originally published in Pharmaceutical Approvals Monthly
Executive SummaryApproval of the lupus treatment prasterone may be delayed, Watson reports in a May 7 conference call. FDA is expected to reach a decision on approvability of the product by the June 26 user fee goal. The potential delay in approval follows an April 19 review by FDA's Arthritis Advisory Committee. The group did not vote on approval, but members expressed concern about Aslera's failure to reach initially defined primary endpoints in the pivotal trials
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