Merck's Gardasil Vaccine Not Approved for Expansion
U.S. regulators did not approve Merck & Co's application to expand marketing of its cervical cancer vaccine Gardasil to an older group of women within an expected review period, the drugmaker said.
Merck had applied for the use of Gardasil in women ages 27 though 45.
The U.S. Food and Drug Administration said in a letter regarding Merck's application that it has completed its review and there are "issues" that preclude approval of the supplement within the expected review time frame, Merck said.
The company said it had already discussed the questions with the FDA and expects to respond to the agency in July.
The letter does not affect Gardasil's current approval for females aged 9 through 26, Merck said.