The U.S. Food and Drug Administration (FDA) yesterday refused to approve Merck & Co’s Gardasil for use by older women aged 27 through 45, saying the agency did not have enough time to address the issues related to the drug and license application.

Actually, Merck & Co wanted to expand the use of cervical cancer vaccine Gardasil, and thus it had written to the FDA to let it market the multi-billion selling cervical cancer vaccine Gardasil for older women, but the FDA denied the request.

In its response letter to Merck & Co on Wednesday, the FDA stated that the agency cannot yet approve Gardasil for use by older women aged 27 through 45, and that the approval will not come before the expected July timeframe.

The FDA explained that they have completed their review of Gardasil, but they cannot yet approve it for use by older women because they do not have enough time to address the issues related to the drug and license application.

Gardasil, which has already been approved for females age 9 to 26 for prevention of cervical cancer induced by a couple of Human papillomavirus (HPV) strains, is Merck’s top selling medication. It earns Merck an estimated 1.5 billion dollars. The vaccine come in three shots and costs $360 per person.