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Sitavig Approval History

FDA Approved: Yes (First approved April 12, 2013)
Brand name: Sitavig
Generic name: acyclovir
Dosage form: Buccal Tablets
Company: BioAlliance Pharma SA
Treatment for: Cold Sores

Sitavig (acyclovir) is a mucoadhesive buccal tablet formulation of the antiviral drug acyclovir indicated for the treatment of recurrent orofacial herpes (cold sores).

Development History and FDA Approval Process for Sitavig

DateArticle
Apr 15, 2013Approval BioAlliance Pharma's Sitavig Receives FDA Approval for the Treatment of Herpes Labialis
Jun  1, 2012BioAlliance Pharma SA : Receivability of Sitavig US Registration Dossier (NDA) for the Treatment of Recurrent Orofacial Herpes Validated by the FDA

Further information

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