GlaxoSmithKline (NYSE:GSK) announced that it has submitted its response to the U.S. Food and Drug Administration to questions the agency had in response to GSK's drug application for Cervarix.
Cervarix, a vaccine for the prevention of cervical cancer, one of the largest drug hopes in Glaxo's pipeline has already been approved in 67 countries but the FDA issued a "Complete Response" letter in December 2008 requiring the company answer questions.
"Study 008 is a key study that will be completing later this year, and
we expect the final results will strengthen the U.S. label for
CERVARIX(R)," said Barbara Howe, M.D., Vice President and Director, North
American Vaccine Development, GlaxoSmithKline. "We continue to have
positive and productive discussions with the FDA and remain confident in
the vaccine's safety and efficacy profile. We look forward to bringing this
important new cervical cancer vaccine to girls and women in the U.S."
[Source: PRNewsWire]
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