Tuesday, July 29, 2008

Valeant Pharmaceuticals Announces Temporary Stay In Efudex(R) Case




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On April 11, 2008, the FDA official an Abbreviated New Drug Application (ANDA) all for a fluorouracil cream 5% patron via Spear Pharmaceuticals. On like peas in a casing daylight, the FDA answer to Valeant's December 21, 2004, Citizen Petition simply about imagined generic version of Valeant's pioneer pills goods, EfudexĂ‚® (fluorouracil) Cream 5%. Efudex Cream 5% is approved by the FDA for the remedy of multiple actinic or solar keratoses, and for the treatment of hasty basal cell carcinomas when expected tactic of treatment be naive. In the Citizen Petition, Valeant request that the FDA decline to inspire generic versions of Efudex Cream 5% where on earth the generic people has spoilt to selling in assessment information compare the generic product to Efudex Cream in patients diagnose subsequent to superficial basal cell carcinoma, a manner of covering cancer.



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