Leading the Way in Life Science Technologies

GEN Exclusives

More »

GEN News Highlights

More »
Jun 25, 2008

FDA Hits Merck & Co. with Double Whammy for Gardasil Label Extensions

  • FDA issued negative reviews of two sBLAs from Merk & Co. related to its HPV vaccine, Gardasil. The agency decided that submitted data did not support approving Gardasil in nonvaccine HPV types.

    In a separate complete response letter, FDA also found problems with the firm’s application to extend the use of the treatment to women between 27 and 45 from its current indication covering ages 9 to 26.

    Merck submitted the sBLA to expand Gardasil’s reach to older women in January, and in March the FDA designated the submission a priority review. Today’s letter from the FDA notes that the identified problems would not allow it to approve the therapy within the review timeframe. Merck expects to respond to the agency in July.



Related content

Be sure to take the GEN Poll

Cancer vs. Zika: What Worries You Most?

While Zika continues to garner a lot of news coverage, a Mayo Clinic survey reveals that Americans believe the country’s most significant healthcare challenge is cancer. Compared to other diseases, does the possibility of developing cancer worry you the most?

More »