The FDA has approved Oravig (miconazole) buccal tablets for the treatment of oropharyngeal candidiasis in adults and childen aged 16 years and older. The drug is the first and only local, oral prescription formulation of miconzole approved for this use in the United States.
Oravig, which is made by Strativa Pharmaceuticals, of Woodcliff Lake, NJ, uses innovative buccal tablet technology that enables once-daily dosing that delivers miconazole directly at the local site of infection throughout the day with minimal systemic absorption.
FDA based its approval on two phase 3 trials, one involving HIV-infected patients and the other involving patients who underwent radiotherapy for head and neck cancer.
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