August 19, 2009
FDA accepts NDA for Miconazole Lauriad, a treatment for oropharyngeal candidiasis (OPC)Strativa (a division of Par Pharmaceuticals) announced that the FDA has accepted for filing the New Drug Application (NDA) submitted for miconazole Lauriad mucoadhesive buccal tablets (MBT) for the treatment of oropharyngeal candidiasis (OPC). The NDA submission was based primarily on data from a randomized, double-blind, double-dummy international study demonstrating noninferiority to Mycelex Troche (clotrimazole) in the complete resolution of signs and symptoms of OPC in 577 HIV-positive patients.
MBT delivers the antifungal miconazole via a mucoadhesive buccal tablet that is designed to enable once-daily dosing of the active ingredient at the site of infection.
For more information call (201) 802-4000 or visit www.strativapharma.com.