GSK Provides Regulatory Update On Rezonic

GlaxoSmithKline (GSK) has received a complete response letter from FDA, related to the application for casopitant (Rezonic). The company is reviewing it and will slot in with the FDA to determine appropriate next steps.

The 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 FDA on May 29, 2008, for the prevention of chemotherapy-induced nausea and vomiting (CINV), and post-operative nausea and vomiting (PONV).

GSK is a UK-based pharmaceutical and healthcare company. The company is focused on respiratory, anti-infectives, gastro-intestinal/metabolic, central nervous system, oncology and vaccines products.