US FDA approves NDA from Actavis and Valeant

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.

Fred Wilkinson, president, Actavis Global R&D, said: “The approval of Metronidazole 1.3% is a significant milestone for Actavis and provides an important new option with a single-dose treatment for women suffering from BV. The expected launch of the product later this year will establish a promising long-term opportunity for Actavis and support the continued growth of our industry-leading Women's Health franchise.”