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). GlaxoSmithKline – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit www.gsk.com GlaxoSmithKline Enquiries: UK Media enquiries: Philip Thomson (020) 8047 5502 David Outhwaite (020) 8047 5502 Stephen Rea (020) 8047 5502 US Media enquiries: Lisa Behrens (919) 483 2839 Ken Inchausti (919) 483 2839 European Analyst/Investor enquiries: David Mawdsley (020) 8047 5564 Sally Ferguson (020) 8047 5543 Gary Davies (020) 8047 5503 US Analyst/ Investor enquiries: Tom Curry (215) 751 5419 Jen Hill Baxter (215) 751 7002 Registered in England & Wales: No. 3888792 Registered Office: 980 Great West Road Brentford, Middlesex TW8 9GS

The release as fetched from its publisher. gsk.com ↗