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Oravig Approval History

FDA Approved: Yes (First approved April 16, 2010)
Brand name: Oravig
Generic name: miconazole
Dosage form: Buccal Tablets
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.

Development History and FDA Approval Process for Oravig

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

Further information

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