Valeant Pharmaceuticals International has received approval from the Food and Drug Administration (FDA) for its Supplemental New Drug Application (sNDA) for Retin-A Micro (tretinoin) Gel microsphere 0.08% for the topical treatment of acne vulgaris.
"We are very pleased that the FDA has approved our new strength of Retin-A Micro as this gives healthcare providers and patients a new option for the topical treatment of acne vulgaris," stated J. Michael Pearson, chairman and CEO of Valeant. "This new strength will provide physicians and patients another effective treatment and should be a welcome alternative to current strengths. We look forward to launching 0.08% Retin-A Micro in the near future."
In clinical trials, the most common adverse reactions were skin pain, pruritus, skin irritation and subcutaneous irritation, pharyngitis and erythema.