Oravig Approval History

• FDA approved: Yes (First approved April 16th, 2010)
• Brand name: Oravig
• Generic name: miconazole
• Previous name: Loramyc
• Company: BioAlliance Pharma SA
• Treatment for: Oral Thrush

Oravig (miconazole) is a mucoadhesive buccal azole antifungal therapy indicated for the local treatment of oropharyngeal candidiasis in adults.

FDA Approval History for Oravig

Date	Article
Apr 16, 2010	FDA Approves Oravig (miconazole) Buccal Tablets for Treatment of Oropharyngeal Candidiasis
Aug 19, 2009	BioAlliance Pharma: FDA Accepts Drug Application for Miconazole Lauriad (Loramyc) to Treat Oropharyngeal Candidiasis
Jun 16, 2009	Bioalliance Pharma Submits Loramyc NDA to US FDA And Announces a General Shareholders' Meeting to Amend Its By-Laws
May  7, 2009	Bioalliance Pharma to Resubmit Loramyc NDA in the Second Quarter of 2009
Apr  9, 2009	Bioalliance Pharma To Complete NDA For Loramyc With Data on Debossed Mucoadhesive Tablet

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Oravig (miconazole) Consumer Information

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