The U.S. Food and Drug Administration, on Wednesday, refused to approve the use of Gardasil, the cervical cancer medication for women between 27 to 45 years.

Manufactured by Merck & Co., Gardasil was approved in 2006 for girls and women between the ages of nine and 26 to prevent cervical cancer caused by the human papillomavirus. The drug company was expecting the FDA’s approval by July.

Gardasil is the only cervical cancer vaccine that has been approved by the FDA for use in the U.S. and it outsells Cervarix, GlaxoSmithKline’s worldwide sales.  

Though the FDA stated that issues had come up regarding the approval of Gardasil for older women, they did not elaborate on what the issues were.

WBB Securities analyst Steve Brozak said, "This is clearly not what Merck wanted. It reflects the painstakingly slow process that the FDA has in approving anything. I think this is one where they would rather err on the side of getting another 23 pounds of documents."

Merck however pointed out that the letter from the FDA does not impact Gardasil for women aged 9 to 26, who could get the vaccine from their doctors.