After the U.S. Food & Drug Administration has requested more information on GlaxoSmithKline PLC’s cervical cancer vaccine Cervarix, the company’s shares fell Monday.
A so-called complete response letter was received by Glaxo - a kind that the U.S. regulator issues when the review of a marketing application file is completed and questions remain to be answered prior to approval.
"We have already started addressing the questions and will be engaged in discussions with the FDA to finalize our responses," said Barbara Howe, GlaxoSmithKline's vice president and director of North American vaccine development.
GlaxoSmithKline shares fell 1.4 percent to 1,305 pence (26.33 dollars; 18.26 euros) on the London Stock Exchange. The company had said earlier that it expected to get the drug, which is expected to become a multibillion-dollar product, to the U.S. market sometime in 2008.