Spear starts shipping generic Efudex

The USA's Spear Pharmaceuticals has begun shipping fluorouracil cream 5%, USP, a generic equivalent to Valeant Pharmaceutical's Efudex Cream. The Food and Drug Administration approved the Abbreviated New Drug Application based on Spear's 318-patient study proving bioequivalence to Efudex for precancerous actinic keratoses, the indication for which the product is overwhelmingly prescribed, constituting about 98% of patients who receive it. The agent is also useful in the treatment of superficial basal cell carcinoma.

Since December 2004, Valeant has taken action to make it far more difficult for any generic Efudex product to gain FDA approval (Efudex was first cleared in 1970 and has been off patent for 20 years.) Specifically, Valeant filed in December 2004 a Citizen Petition that delayed the approval of the Spear generic product from the industry average of 16.6 months to 39 months.