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.
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.
Perrigo announces tentative FDA approval for the generic version of Soolantra® cream, 1% [press release]. Dublin; PRNewswire: January 30, 2018. Accessed February 1, 2018.
This article originally appeared on MPR