Valeant announces Spear to halt generic Efudex persuant to lawsuit against FDA

ALISO VIEJO, Calif. Spear Pharmaceuticals has agreed to not market, sell or ship the drug fluorouracil cream 5 percent, a generic of Valeant Pharmaceuticals Efudex in relation to legal action Valeant is taking against the Food and Drug Administration. The agreement to hold off the generic will remain in place until at least May 14.

On April 11, the FDA approved an application for a fluorouracil cream 5 percent sponsored by Spear Pharmaceuticals. On the same day, the FDA responded to Valeant’s Dec. 21, 2004, citizen petition regarding potential generic versions of Valeant’s pioneer drug product, Efudex.

The drug is approved by the FDA 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.

In the citizen petition, Valeant requested that the FDA decline to approve generic versions of Efudex where the generic company has failed to provide test data comparing the generic product to Efudex in patients diagnosed with superficial basal cell carcinoma, a form of skin cancer.

On April 25, Valeant filed a federal lawsuit against the secretary of Health and Human Services, Michael Leavitt, and the commissioner of the FDA, Andrew von Eschenbach, challenging the FDA’s denial of Valeant’s citizen petition and the approval of a generic to Efudex. Valeant requested a temporary restraining order to suspend the FDA’s approval of Spear’s application. Following an initial round of briefing, the FDA requested and obtained from the court a two week wait of the lawsuit. In addition, Spear Pharmaceuticals informed the court it will suspend all further sales and shipment of its product for the duration of the court ordered stay.