Xerese
Generic name: acyclovir and hydrocortisone
Treatment for: Cold Sores
Marketing Authorization Application for Lipsovir Now Validated by American and European Regulatory Authorities
HUDDINGE, Sweden, Dec. 8, 2008--Medivir announced today that the American (FDA) and European regulatory authorities have validated the NDA and Marketing Authorization Application for 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 third quarter 2009.
Lipsovir is a topical product for 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.
For additional information please contact Rein Piir, CFO & VP, Investor Relations at Medivir, +46 8 5468 3123 or +46 708 537292
Posted: December 2008
Related articles
- The US FDA approves Lipsovir for marketing and sales in US - August 4, 2009
- New Drug Application (NDA) for Lipsovir submitted to US FDA - October 1, 2008
Xerese (acyclovir and hydrocortisone) FDA Approval History
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