New Jersey, US- based Strativa ,the proprietary products division of a wholly owned subsidiary of Par declared that its development partner, BioAlliance has submitted a New Drug Application (NDA) to the FDA.
BioAlliance has submitted the NDA for Loramyc (miconazole Lauriad) 50mg mucoadhesive buccal tablets. If approved, Strativa is expecting to launch Loramyc in the second half of 2010.
Loramyc (miconazole Lauriad), an antifungal therapy for the treatment of oropharyngeal candidiasis, was approved in the EU in 2007 and is currently marketed in several EU territories.