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Valeant Pharmaceuticals Announces FDA Has Initiated Reconsideration of Generic Efudex Approval
- (NewsRx.com) -- Valeant Pharmaceuticals (NYSE:VRX) 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,...

Macro World Investor: Jun 11 2008 10:44PM
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Calibre Macro World: Jun 11 2008 10:38PM
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Spear wins approval for Fluorouracil cream 5%
The FDA approved the abbreviated new drug application based on Spear's 318 patient study proving bioequivalence to Efudex for the precancerous actinic keratoses skin condition, the indication for which the product is overwhelmingly...

Pharmaceutical Business Review: May 23 2008 2:21AM
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Valeant Pharma: FDA has initiated reconsideration of generic Efudex approval
NEW YORK (Thomson Financial) - Valeant Pharmaceuticals International Thursday said the Food and Drug Administration has entered an administrative order to stay the approval of generic fluorouracil cream 5% until May 30 because of ...

Sharewatch: May 15 2008 1:21PM
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Valeant obtains stay against Spear in Efudex case
Valeant Pharmaceuticals announced that Spear Pharmaceuticals has agreed not to market, sell or ship a generic fluorouracil cream 5 per cent pursuant to a stay in Valeant's legal case against the Food and Drug Administration (FDA).

The stay...

PharmaBiz: May 7 2008 11:49AM
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