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Valeant says FDA stays approval of competing drug
Thursday May 15, 8:59 am ET
Valeant Pharmaceuticals says the FDA stayed approval of a generic chemotherapy competitor

ALISO VIEJO, Calif. (AP) -- Valeant Pharmaceuticals International said Thursday the Food and Drug Administration stayed its approval decision on a competing version of its topical chemotherapy treatment Efudex.

The company is in a patent dispute with Spear Pharmaceuticals and that company's recent approval of a generic form of its skin cancer drug. The FDA has now stayed its approval decision made in April to consider whether it required all the necessary information in the generic drug application.

The move puts the approval decision on hold until May 30.

Valeant filed a federal lawsuit against both the Secretary of Health and Human Services, Michael O. Leavitt, and FDA Commissioner, Dr. Andrew C. von Eschenbach, M.D., challenging the denial of a Valeant petition and the approval of generic Efudex.

Spear has committed to suspending further sales of the generic drug until at least May 30.

Shares of Valeant closed at $15.98 Wednesday.