FDA News Roundup: HPV vaccine indication expanded

September 17, 2008

The Food and Drug Administration (FDA) expanded its indication of the human papillomavirus (HPV) vaccine Gardasil to include vaginal and vulvar cancer in girls and women ages 9 to 26.

Drug indication expansion


The Food and Drug Administration (FDA) expanded its indication of the human papillomavirus (HPV) vaccine Gardasil to include vaginal and vulvar cancer in girls and women ages 9 to 26.

The expansion was prompted by results from a two-year follow-up analysis by Merck, Gardasil's manufacturer. Among participants who tested negative for HPV types 16 and 18, the drug was found to be highly effective in preventing HPV-related precancerous vulvar and vaginal lesions, the FDA stated. The vaccine showed no benefit for participants who were previously infected with HPV before immunization.

In addition, Gardasil's label has been revised to show that Gardasil does not protect against diseases caused by HPV types not contained in the vaccine.

Import alert issued
The FDA issued an import alert for generic drugs produced by Ranbaxy Laboraties Ltd.'s Dewas and Paonta Sahib plants in India, as well as two warning letters to Ranbaxy. The FDA has stated it detected deficiencies in the company's drug manufacturing process, which may deviate from current U.S. Good Manufacturing Practice requirements.

Although the import alert does authorize U.S. border officials to detain any active pharmaceutical ingredients, and both sterile and non-sterile finished drug products, manufactured at the two Ranbaxy plants, it does not involve removing relevant drugs from the market. There is currently no evidence showing defective products have been shipped to the U.S., the FDA stated.