Merck & Co's Gardasil BLA "on track"
US drug major Merck & Co. has announced that the Food and Drug Administration Biologics License Application for Garasil (quadrivalent human papillomavirus types 6, 11, 16, 18, recombinant vaccine) is "on track and pending acceptance."
Merck delivered the completed file to the FDA on December 1. Following the submission, the agency informed the company that the submission date is officially December 8. Within 60 days following the official filing, the FDA will determine whether it will accept for review Merck's application as submitted.
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