FDA Approves Lipsovir
The US FDA approves Lipsovir for marketing and sales in US
STOCKHOLM, Sweden, Aug. 3, 2009--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.
"It's enormously satisfying to have our herpes product approved by the FDA, in the form we had intended and according to the time plan. We are extremely pleased to be awarded such a clear and strong label. We will be intensifying our activities towards securing a commercialization agreement for US marketing and sales, to ensure the greatest possible value for Medivir", says Eva Arlander, VP Medivir Pharma.
Medivir will be represented by Rein Piir CFO & VP IR and Eva Arlander VP Pharma, and also project director for Lipsovir.
For additional information, please contact: Rein Piir, CFO & VP Investor Relations, Medivir +46 708 537 292.
For more information on Medivir, please see the company website: www.medivir.se
Posted: August 2009
Related articles
- Marketing Authorization Application for Lipsovir Now Validated by American and European Regulatory Authorities - December 8, 2008
- New Drug Application (NDA) for Lipsovir submitted to US FDA - October 1, 2008
Xerese (acyclovir and hydrocortisone) FDA Approval History
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