Perrigo receives tentative FDA approval for generic scalp dermatosis drug

Patent infringement suit over clobetasol propionate emulsion foam still pending, drug maker says

ALLEGAN, Mich. — The Food and Drug Administration has granted tentative approval to a drug made by Perrigo for dermatosis of the scalp.

Perrigo's clobetasol propionate emulsion foam in the 0.05% strength is a generic version of Stiefel Labs' Olux-E Foam. Sales for the branded version of the drug were $40 million during the 12-month period ended in September, according to Wolters Kluwer.

Last July, an Australian subsidiary of Stiefel sued Perrigo for patent infringement in the U.S. District Court for the District of Delaware to prevent the latter from launching the drug. The FDA's tentative approval means that the drug meets the agency's safety and effectiveness requirements, but can't receive final approval until Olux-E's patent protection no longer is in effect.

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