Barrier Therapeutics has announced the FDA’s approval of the company’s application to add clinical data to the prescribing information for mequinol 2%, tretinoin 0.01% topical solution (Solage). The revised labeling states that Solage is safe and effective for darker skin types.
The new prescribing information includes data from a phase 4 post-approval study showing a favorable benefit-to-risk ratio in the treatment of solar lentigines in African-American, Asian, and Latin or Hispanic patients. These results were consistent with findings previously reported for Caucasians. canadian pharmacy cialis
In the U.S., the solution is used to treat solar lentigines; in Canada, it is also used to treat related hyperpigmented lesions.
Solage is the only FDA-approved combination skin-lightening agent that does not contain hydroquinone.