Gardasil Label Expansion To Women 27-45 Delayed Until 2010, At The Earliest
This article was originally published in The Pink Sheet Daily
Executive Summary
Merck receives a second “complete response” letter from FDA related to its sBLA to extend indications for the vaccine to older women.
You may also be interested in...
Third Time Is Not A Charm For Merck's Bid To Expand Gardasil Use To Older Women
FDA rejects broader indication for the HPV vaccine and revises labeling to include information about a lack of demonstrated efficacy in women older than 26.
Third Time Is Not A Charm For Merck's Bid To Expand Gardasil Use To Older Women
FDA rejects broader indication for the HPV vaccine and revises labeling to include information about a lack of demonstrated efficacy in women older than 26.
Third Time Is Not A Charm For Merck's Bid To Expand Gardasil Use To Older Women
FDA not only has declined to approve Merck's human papillomavirus vaccine Gardasil for use in women ages 27-45, it has added to labeling a statement that the vaccine was not shown effective in preventing more serious HPV-related precancerous cervical lesions or cancer in the pivotal study targeting this age group.