Bacterial Vaginosis
Mission Pharmacal submits sNDA to U.S. FDA for tinidazole as bacterial vaginosis treatment
Published in Women's Health Weekly, September 14th, 2006
Mission Pharmacal announced that the company has submitted a supplemental new drug application (sNDA) with the U.S. Food and Drug Administration (FDA) for a new indication for Tindamax (tinidazole) as treatment of bacterial vaginosis (BV), the most common vaginal infection in the United States. If the sNDA is approved by the FDA, Tindamax would provide a shorter course oral treatment option than the current standard of care used to treat bacterial vaginosis.
The sNDA for Mission Pharmacal is supported by data from a randomized, placebo-controlled, double-blind multicenter trial evaluating two dosing regimens of Tindamax (tinidazole). In the study, patients with BV were...
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