Watson Aslera
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Lupus therapy prasterone is deemed "not approvable" June 26. FDA was concerned about "interpretation of efficacy and safety data submitted in the NDA," Watson says. The NDA, submitted September 2000, was granted fast-track status. In March the review time was extended to June 26
Lupus therapy prasterone is deemed "not approvable" June 26. FDA was concerned about "interpretation of efficacy and safety data submitted in the NDA," Watson says. The NDA, submitted September 2000, was granted fast-track status. In March the review time was extended to June 26. |