The United States Food and Drug Administration (FDA) did not accept Merck & Co., Inc’s supplemental biologics license application (sBLA) for its vaccine Gardasil® (human papillomavirus quadrivalent [Types 6, 11, 16, 18] vaccine, recombinant). The sBLA was submitted to expand the indication of Gardsil to women aged 27 through 45. Gardasil is already approved for women aged 9 through 26, and is indicated for the prevention of the most common types of HPV, which are known to cause cervical cancer.
Merck & Co., Inc expects to respond to the FDA with their questions regarding the sBLA for Gardasil by next month.
© 1998-2007 OncoEd.com All Rights Reserved.
These materials may discuss uses and dosages for therapeutic products that have not been approved by the United States Food and Drug Administration. All readers should verify all information and data before administering any drug, therapy or treatment discussed herein. Neither the editors nor the publisher accepts any responsibility for the accuracy of the information or consequences from the use or misuse of the information contained herein.
Patient Home
