Valeant announced that the FDA has approved its supplemental New Drug Application (sNDA) for Retin-A Micro (tretinoin) gel microsphere 0.08%, a new strength of Retin-A Micro gel. Retin-A Micro gel is indicated for the treatment of acne vulgaris.

The exact mechanism of tretinoin is unknown, but evidence suggests that the effectiveness of tretinoin in acne is due primarily to its ability to modify abnormal follicular keratinization. By increasing the mitotic activity of follicular epithelia, tretinoin also increases the turnover rate of thin, loosely-adherent corneocytes. Through these actions, the comedo contents are extruded and the formation of the microcomedo, the precursor lesion of acne vulgaris, is reduced.

Retin-A Micro gel is already available in 0.04% and 0.1% strengths. The new 0.08% strength gel is expected to launch in the near future.

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