Estimated FDA User Fee Review Goals For Pending NDAs/BLAs
This article was originally published in Pharmaceutical Approvals Monthly
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Amylin’s recent Symlin NDA amendment shows that a dose titration regimen reduces the risks of nausea and hypoglycemia in type 1 and 2 diabetes patients, the firm reported June 15.
European review documents for Oxford GlycoSciences/Actelion’s Gaucher disease treatment Zavesca raise two concerns that are likely issues in FDA’s review: comparative efficacy to enzyme replacement therapy and neurological adverse events.