BioAlliance, the development partner of US company Strativa, has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA).
The NDA has been submitted for Loramyc (miconazole Lauriad) 50mg mucoadhesive buccal tablets, an antifungal therapy for the treatment of oropharyngeal candidiasis.
Loramyc (miconazole Lauriad) was approved in the EU in 2007 and is marketed in several EU territories.
If approved, Strativa is expecting to launch Loramyc in the US in the second half of 2010.
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