FDA approves new drug for treatment of cold sores

August 7, 6:06 AMInfectious Disease ExaminerRobert Herriman

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The US Food and Drug Administration (FDA) have approved a new drug for treating cold sores.

Lipsovir (Medivir AB) is a patented combination of hydrocortisone (an anti-inflammatory agent) and acyclovir (an antiviral) intended for the topical treatment of cold sores.

Like other cold sore pharmaceuticals, Lipsovir will be a prescription product in the US. The label, that is the indication text endorsed by the FDA, states “Acyclovir and Hydrocortisone Cream is indicated for the early treatment of recurrent herpes labialis (cold sores) to reduce the likelihood of ulcerative cold sores and to shorten the lesion healing time”.

Treatment is approved for adults and children aged 12 years and older.

No product currently marketed for the treatment of cold sores has a corresponding label or has been shown to prevent an outbreak with early treatment according to a Medivir press release.

Medivir AB