FDA law blog:FDA Sued After Denying Citizen Petition and Approving Generic EFUDEX Cream ANDA; Agency Will Reconsider ANDA Approval

Valeant Pharmaceuticals International’s (“Valeant’s”) EFUDEX (fluorouracil) Topical Cream, 5%, (also known as 5-FU) is a locally-acting antineoplastic drug product FDA first approved in July 1970 for the topical treatment of multiple actinic or solar keratoses (“AK”). In 1976, FDA approved the drug for a second indication - for the topical treatment of superficial basal cell carcinomas (“sBCC”) when conventional methods are impractical. In December 2004, Valeant submitted a citizen petition to FDA requesting that the Agency not approve any Abbreviated New Drug Application (“ANDA”) for a generic version of EFUDEX Cream unless the application contains data from an adequately designed comparative clinical study conducted in sBCC subjects. Specifically, Valeant argues in the company’s petition that: Link to FDA law blog for full article