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FDA grants Gardasil two new indications
Some good news for Merck's Gardasil: The FDA says the human papillomavirus vaccine is approved for prevention of vulvar and vaginal cancers, in addition to its current use as a cervical cancer shot. The new indications come at a good time, when Gardasil was faltering on lower-than-expected use among women 19 to 26. And Merck lost its FDA bid for approval in older women, so it couldn't mount a marketing push for that segment of the market.
Now, the company can tout increased protection. "This is fabulous stuff," said Rick Haupt, Merck's program leader for Gardasil.
Next up: data on the use of Gardasil in men. The company hopes to submit a study in support of that new indication by year's end.
- read the FDA release
- check out the story in the New York Times
Related Articles:
Analyst gloomy on Merck trends
Study questions Gardasil's payback
Gardasil side effects prompt CDC study
Is Gardasil worth the cost?
Gardasil "remarkably safe," despite anaphylaxis
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