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news.Spear Pharmaceuticals has received the FDA approval for, and began shipping, Fluorouracil cream 5%, USP, a generic equivalent to Valeant's Efudex cream.
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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 prescribed (approximately 98% of patients). The product is also useful in the treatment of superficial basal cell carcinoma (sBCC).
The FDA approved the Spear product based on precedent and pursuant to its well established scientific, medical, and statistical review procedures for determining bioequivalence.