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FDA Accepts Drug Application for Miconazole Lauriad(R) to Treat Oropharyngeal Candidiasis
Date:8/19/2009

WOODCLIFF LAKE, N.J., Aug. 19 /PRNewswire-FirstCall/ -- Strativa Pharmaceuticals, the proprietary products division of a wholly owned subsidiary of Par Pharmaceutical Companies, Inc. (NYSE: PRX), today announced that the U.S. Food and Drug Administration (FDA) has accepted the new drug application (NDA) for miconazole Lauriad((R)) 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((R)) Troche (clotrimazole)* in the complete resolution of signs and symptoms of OPC. The randomized, double-blind, double-dummy study was conducted in 577 HIV-positive patients in 40 sites in the United States, Canada, and South Africa.

"The NDA acceptance of miconazole MBT represents a significant milestone for Strativa Pharmaceuticals as this would be the first oral miconazole therapy available in the U.S. and would provide healthcare providers with a new option for treating OPC," said John A. MacPhee, president of Strativa Pharmaceuticals. "We believe miconazole MBT's delivery system and once-daily dosing schedule will offer an effective, convenient alternative to currently available local therapies, which require several doses per day to treat OPC." Strativa could launch miconazole MBT in the second half of 2010, if approved.

OPC, familiarly known as thrush, is an oral fungal infection most common in individuals with weakened immune systems -- particularly those with HIV/AIDS and those undergoing cancer treatments. OPC is a disruptive condition that results in les
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SOURCE Par Pharmaceutical Companies, Inc.
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