May 15, 2008 - Valeant Pharmaceuticals (NYSE:VRX) today announced that the Food and Drug Administration (the FDA) has entered an administrative order "in the public interest" to stay the approval of generic fluorouracil cream 5% until May 30, 2008 "because there are outstanding questions regarding this approval that the Agency must consider." The FDA hopes to conclude its review by May 30, 2008 and Spear has agreed to an administrative stay of its ANDA approval until May 30, 2008. According to the administrative order by the FDA, signed by Associate Commissioner for Policy and Planning, Jeffrey Shuren, "marketing, sales and shipment under ANDA 77-524 are prohibited during the pendency of this administrative stay."
The details can be read here.
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