GlaxoSmithKline: FDA Requests More Information About Booster Shot

11th Jun 2010 22:59

DOW JONES NEWSWIRES GlaxoSmithKline PLC (GSK, GSK.LN) said U.S. regulators have asked it to answer some questions about the company's proposed dual vaccine for two bacterial diseases before issuing an approval. The company said it received a complete response letter about the booster shot from the Food and Drug Administration, which the FDA sends when it has completed a review of an application's file but needs some more questions answered. The shot, which it calls MenHibrix, is a vaccine for two serogroups of meningococcal disease and haemophilus influenzae type b, both bacterial infections. The company said it would respond to the FDA's questions and remained committed to making the MenHibrix vaccine available in the U.S. Glaxo shares closed up 2% at $34.97 Friday. The stock has fallen 17% in the last year, underperforming the market at large. -By Joan E. Solsman, Dow Jones Newswires; 212-416-2291; [email protected] (END) Dow Jones Newswires June 11, 2010 17:59 ET (21:59 GMT)