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Perrigo Emulsion Foam ANDA wins FDA tentative approval

The US Food and Drug Administration (FDA) has awarded a tentative approval to Perrigo's Abbreviated New Drug Application (ANDA) for Clobetasol Propionate Emulsion Foam, 0.05% to treat moderate to severe dermatosis of the scalp.

Stiefel Research Australia has filed a patent infringement suit in the US District Court for the District of Delaware against Perrigo to stop marketing its Emulsion Foam.

The patent infringement suit was filed because Perrigo’s Clobetasol was similar to Stiefel Laboratories’ topical corticosteroid – Olux -E Foam, 0.05%.

Perrigo manufactures OTC pharmaceutical products and infant formulas and generic prescription (Rx) pharmaceuticals, infant formulas, nutritional products, and active pharmaceutical ingredients (API).