Galderma announced that the Food and Drug Administration (FDA) has approved Soolantra (ivermectin) Cream for the topical treatment of inflammatory lesions of rosacea.

The exact mechanism of ivermectin is unknown. However, it is reported to have anti-inflammatory and antiparasitic activity.

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The FDA approval was supported by two Phase 3, multicenter, randomized, double-blind, 12-week, vehicle-controlled parallel-group studies. Soolantra Cream achieved each of its co-primary efficacy endpoints and treatment effect was seen as early as Week 2 with continuous improvement. Data from the long-term extension studies showed that Soolantra Cream was also safe and well-tolerated for another 40 weeks (up to 52 weeks total). In a separate head-to-head study vs. metronidazole 0.75% cream, treatment with Soolantra Cream was more effective from as early as Week 3 onward.

Soolantra Cream will be available as a 1% strength in 30g tubes.

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