Valeant Announces FDA Approval

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 percent 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,” says J. Michael Pearson, chairman and CEO of Valeant. “This new strength will provide physicians and pa- tients 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.

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