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Home » MISSION APPLIES FOR NEW INDICATION FOR TINDAMAX
MISSION APPLIES FOR NEW INDICATION FOR TINDAMAX
August 21, 2006
Mission Pharmacal has submitted a supplemental new drug application with the FDA for a new indication for Tindamax (tinidazole) as treatment of bacterial vaginosis, the most common vaginal infection in the United States. If approved by the FDA, Tindamax would provide a shorter course oral treatment option than the current standard of care.
The application is supported by data from a randomized, placebo-controlled, double-blind multicenter trial evaluating two dosing regimens of the drug. In the study, patients were randomized to one of three treatment arms: 2 g of Tindamax once daily for two days, 1 g of Tindamax once daily for five days or placebo.
The drug is currently approved for the treatment of trichomoniasis, the intestinal infections giardiasis and intestinal amebiasis, and amebic liver abscess.
KEYWORDS Drug Pipeline Alert
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