BOSTON (Thomson Financial) - Merck & Co. said Wednesday that it receieved a
complete response letter from the Food and Drug Administration for the company's
cervical cancer drug Gardasil in women ages 27 through 45.
The letter states that the FDA has completed its review of Merck's request
for a supplemental biologics license and that issues preclude the approval of
the supplement within the expected review timeframe.
Merck said it has already discussed their questions with the FDA related to
the application and expects to respond to the agency in July.
The company noted that the letter doesn't affect current indications for
Gardasil in females age 9 through 26.
Merck also reiterated its confidence in its 4% to 6% compound annual revenue
growth goal from 2005 to 2010, including all joint-venture revenue and
double-digit compound annual earnings-per-share growth from 2005 to 2010.
Shares of the Whitehouse Station, N.J.-based drug manufacturer closed
Tuesday at $37.03.
Greg Saulnier
gs/pc
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