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Xerese FDA Approval History

FDA Approved: Yes (First approved July 31, 2009)
Brand name: Xerese
Generic name: acyclovir and hydrocortisone
Dosage form: Topical Cream
Previous Name: Lipsovir
Company: Meda Pharmaceuticals Inc.
Treatment for: Cold Sores

Xerese (acyclovir and hydrocortisone) is a topical antiviral and anti-inflammatory combination for the prevention and treatment of cold sores.

Development timeline for Xerese

Aug  4, 2009Approval The US FDA approves Lipsovir for marketing and sales in US
Dec  8, 2008Marketing Authorization Application for Lipsovir Now Validated by American and European Regulatory Authorities
Oct  1, 2008New Drug Application (NDA) for Lipsovir submitted to US FDA

Further information

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