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Unapproved New Drug: Any substance that has not completed the formal FDA approval process and fails to qualify for a strict 503A or 503B exemption is classified as an unapproved new drug, the distribution of which is prohibited in interstate commerce

Although various therapeutic modality including systemic and topical pharmacological and procedural treatments are commonly available for melasma management, however, many of these treatments showed limited clinical response and accompany numerous unwanted adverse drug reactions

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