The U.S. Food and Drug Administration (FDA) told GlaxoSmithKline PLC that the pharmaceutical giant will have to wait on approval of its cervical-cancer vaccine Cervarix. The agency told GSK that while the drug?s review is finished, regulators still have questions about the drug that need to be answered before they will issue an approval.

Cervarix is slated to compete against Gardasil, a collaboration of Merck & Co. and Sanofi-Aventis SA, in the vital U.S. market. Gardasil sales topped $1.1 billion in the first nine months of 2007. Both vaccines protect against cancer-causing strains of sexually transmitted human papillomavirus (HPV).

?We have already started addressing the questions and will be engaged in discussions with the FDA to finalize our responses,? said a GSK spokeswoman.

Source: Elena Barton, ?Glaxo Cancer-Drug Approval Delayed,? Wall Street Journal, December 18, 2007.