US FDA approves NDA from Actavis and Valeant

26 March 2014
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US generics major Actavis (NYSE: ACT) and Canada’s Valeant Pharmaceuticals (NYSE: VRX) said that the US Food and Drug Administration has approved the New Drug Application for Metronidazole 1.3% Vaginal Gel, an antibiotic for the treatment of bacterial vaginosis (BV).

Actavis acquired the rights to the drug from Valeant in April 2013. Bacterial vaginosis is an infection caused by an imbalance in the normal bacteria in the vagina. It is the most common vaginal infection in women ages 15 to 44. The US BV market is valued at approximately $140 million annually, according to IMS Health.

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