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Medivir’s Lipsovir MAA wins validation from regulatory authorities

Sweden-based pharmaceutical company Medivir has announced that the FDA and European regulatory authorities have validated the new drug application and marketing authorization application for the company's Lipsovir.

The authorities will start the review process to evaluate the data submitted by Medivir. The outcome of this review is expected to be received in the late part of the third quarter of 2009.

Lipsovir is a topical product for the prevention and treatment of cold sores. Lipsovir is a patented combination of hydrocortisone (an anti-inflammatory agent) and acyclovir (an antiviral agent) in a proprietary cream base developed by Medivir.