Draft Guidance for Industry on OTC Treatment of Herpes Labialis With Antiviral Agents; Availability

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The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``OTC Treatment of Herpes Labialis with Antiviral Agents.'' Recent interest in marketing antiviral agents over-the-counter (OTC) to treat herpes labialis has raised public health concerns. This draft guidance summarizes the agency's current thinking on why it does not favor the OTC treatment of herpes labialis with antiherpes agents at this time. The guidance also describes issues that sponsors should consider before submitting a marketing application for an OTC antiviral product to treat herpes labialis.