Actavis, Valeant announce FDA approval for Metronidazole gel

DUBLIN and LAVAL, Quebec — Actavis and Valeant Pharmaceuticals International announced that the Food and Drug Administration approved the new drug application for Metronidazole 1.3% vaginal gel.

The antibiotic is used for the treatment of bacterial vaginosis, an infection caused by an imbalance in the normal bacteria of vagina. It's the most common vaginal infection in women ages 15 years to 44 years. Metronidazole 1.3% provides a single-dose treatment that is packaged in a pre-filled disposable applicator.

"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," said Fred Wilkinson, president of Actavis Global R&D. "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."

Actavis acquired the rights to Metronidazole 1.3% from Valeant Pharmaceuticals International in April 2013. Under the terms of the agreement, Actavis will acquire the rights to the drug for up to $57 million in upfront payments, milestone payments and certain guaranteed royalty payments during the first three years of commercialization, the companies said. The bacterial vaginosis market in the United States is valued at approximately $140 million annually, according to IMS Health.


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