Medivir's Lipsovir gets US FDA nod for cold sores

The US Food and Drug Administration (FDA) has now approved Lipsovir, i.e. granted Medivir's New Drug Application (NDA) for the use of acyclovir and hydrocortisone for early treatment of recurrent cold sores to decreases the risk of cold sores, and to shorten the healing time for those cold sores which are not prevented. Treatment is approved for adults and children 12 years or older.

Like other cold sore pharmaceuticals Lipsovir will be a prescription (Rx) 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."

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. This gives Medivir a clear competitive edge on the US market, which is the most important, and economically speaking the greatest single, market.