BioCentury on BioBusiness,
Gilead: looking past Vistide
Monday, October 9, 1995
Gilead Sciences Inc. filed its NDA for Vistide cidofovir ahead of schedule, which means that its first product could be six months away from commercialization assuming it receives priority review under the FDA’s accelerated review system.
The Foster City, Calif., company is asking for approval as a first-line intravenous treatment of cytomegalovirus retinitis in patients with AIDS. GILD expects to file for European approval by the end of the year, and anticipates that the review process will take a bit longer than in the U.S. — about 9-12 months.
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