Regulatory update for REZONIC™ (casopitant mesylate)

GlaxoSmithKline (NYSE: GSK) confirmed today that it has received a complete response letterfrom the FDA related to the application for casopitant. 

The company is reviewing this letter and will engage with the FDA to determine appropriate next steps.

A complete response letter is issued by FDA’s Center for Drug Evaluation and Research (CDER) when the review of a file is completed and questions remain that preclude the approval of the application. 

Casopitant was originally filed with the FDA on 29 May 2008, for the prevention of chemotherapy-induced nausea and vomiting (CINV) and post-operative nausea and vomiting (PONV). 

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