FDA Postpones Decision On Wider Gardasil Use

Pharmalot

by Ed Silverman
June 16, 2010

Yet another setback for Merck, at least for now. The FDA has postponed a decision to broaden usage of its Gardasil HPV vaccine to women between the ages of 27 and 45. Earlier this year, the drugmaker submitted new data to the FDA and had hoped to hear by the end of June, but a Merck spokeswoman tells us the agency will now respond by the end of 2010.

The drugmaker has been repeatedly frustrated in its quest to widen the market for Gardasil. The vaccine is already approved to protect against some strains of the human papillomavirus, which can lead to cervical cancer, in girls and women ages 9 to 26. Gardasil is also approved to prevent genital warts in males of the same age.

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Author: Leslie Carol Botha

Author, publisher, radio talk show host and internationally recognized expert on women's hormone cycles. Social/political activist on Gardasil the HPV vaccine for adolescent girls. Co-author of "Understanding Your Mood, Mind and Hormone Cycle." Honorary advisory board member for the Foundation for the Study of Cycles and member of the Society for Menstrual Cycle Research.