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news.Irish pharmaceutical firm Actavis and Canada-based Valeant Pharmaceuticals International have announced that the US Food and Drug Administration (FDA) has approved the new drug application (NDA) for Metronidazole 1.3% Vaginal Gel, an antibiotic for the treatment of bacterial vaginosis (BV).
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In April 2013, Valeant offered Actavis the rights to Metronidazole 1.3%, which provides a convenient, single-dose treatment for BV.
BV is an infection caused by an imbalance in the normal bacteria in the vagina and it is the most common vaginal infection in women ages 15 to 44.
Actavis Global R&D president Fred Wilkinson said the approval of Metronidazole 1.3% is a significant milestone for the company 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," Wilkinson said.
As part of the deal with Valeant, Actavis will acquire the rights to Metronidazole 1.3% for up to $57m in upfront payments, milestone payments and certain guaranteed royalty payments during the first three years of commercialization, depending on market conditions.
Actavis will also pay ongoing royalties after the first three years of commercialization.
Actavis develops and manufactures generic, brand, branded generic, legacy brands and over-the-counter (OTC) pharmaceutical products.