Generics of Valeant's Efudex delayed by FDA until end of month

ALISO VIEJO, Calif. Valeant Pharmaceuticals was informed by the Food and Drug Administration that the agency has entered an administrative order “in the public interest” to delay the approval of a generic version of its drug Efudex cream 5 percent until May 30.

The FDA is taking this extra time, “because there are outstanding questions regarding this approval that it must consider.” The agency originally approved the generic form of the drug, fluorouracil cream 5 percent, back on April 11 for Spear Pharmaceuticals.

On the same day, the FDA responded to Valeant’s Dec. 21, 2004, Citizen Petition regarding potential generic versions of Efudex cream 5 percent. In the Citizen Petition, Valeant requested that the FDA decline to approve generic versions of the drug where the generic company has failed to provide test data comparing the generic product to Efudex Cream in patients diagnosed with superficial basal cell carcinoma, a form of skin cancer.

The drug is approved for the treatment of multiple actinic or solar keratoses, and for the treatment of superficial basal cell carcinomas when conventional methods of treatment are impractical.

The agency hopes to have the matter resolved by May 30 and Spear has agreed to halt production and launch of the generic until that date.