Starpharma Holdings Ltd. said the Japanese Pharmaceuticals and Medical Devices Agency granted it final approval to market its VivaGel condom.
The Australian company's commercial partner in Japan, Okamoto Industries Inc., plans to launch the product in the first half of 2019.
Starpharma will receive royalty payments under its license with Okamoto Industries, which holds the majority share of Japan's condom market, according to a news release.
The VivaGel condom is already approved for sale in Australia and Canada under the Lifestyles Dual Protect brand.
Recently, the U.S. Food and Drug Administration asked for confirmatory clinical data in order to approve the company's antibacterial gel VivaGel BV, a treatment for bacterial vaginosis, a common bacterial infection in women.