HIV/AIDS Co-Infection
FDA Accepts Drug Application for Miconazole Lauriad(R) to Treat Oropharyngeal Candidiasis
Published in Medical Letter on the CDC and FDA, September 6th, 2009
Strativa Pharmaceuticals, the proprietary products division of a wholly owned subsidiary of Par Pharmaceutical Companies, Inc. (NYSE:PRX), announced that the U.S. Food and Drug Administration (FDA) has accepted the new drug application (NDA) for miconazole Lauriad mucoadhesive buccal tablets (MBT) to treat oropharyngeal candidiasis (OPC). Miconazole 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.
The NDA submission was based primarily on data from a Phase III study demonstrating noninferiority to Mycelex Troche (clotrimazole)* in the complete...
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