The Food and Drug Administration (FDA) has given tentative approval to Perrigo‘s Ivermectin Cream, the generic version of Galderma‘s Soolantra cream, 1%.

Ivermectin cream is a semi-synthetic derivative isolated from the fermentation of Streptomyces avermitilis that belongs to the avermectin family of macrocyclic lactones. It is indicated to treat inflammatory lesions of rosacea.  

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Ivermectin was initially approved by the FDA in December 2014. In a Phase 3 head-to-head study vs metronidazole 0.75% cream, ivermectin cream proved more effective from Week 3 onward.

Perrigo reached a settlement with Galderma Laboratories and Nestle Skin Health concerning this generic version of Soolantra. 

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