Spear Pharmaceutical Inc.'s ANDA for Fluorouracil Cream 5%
On April 11, 2008, Spear Pharmaceuticals, Inc. received FDA approval for, and began shipping, Fluorouracil Cream 5%, USP, (5FU), a generic equivalent to Valeant's Efudex® Cream. The FDA approved the ANDA (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.
Spear is pleased to be able to offer its generic 5FU product to our customers, physicians and patients. We look forward to bringing additional pharmaceutical products to market in the months and years ahead.