VivaGel® Condom Receives Final Regulatory Approval in Japan
STARPHARMA HLDGS S/ADR (SPHRY)
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Source: Business Wire
MELBOURNE, Australia--(BUSINESS WIRE)-- Starpharma (ASX: SPL, OTCQX: SPHRY) today announced that the VivaGel® condom has received final regulatory approval and is now able to be marketed in Japan, following the completion of the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) review of the product's medical device classification and associated data. This final approval follows on from the previously granted regulatory certification, which was attained for the VivaGel® condom. Starpharma has worked closely with its commercial partner for Japan, Okamoto Industries (Okamoto), throughout the regulatory process. Okamoto has already commenced key launch preparations, including labelling and manufacturing activities, and plans to launch the VivaGel® condom in the first half of 2019. Starpharma will be eligible to receive royalty payments under its licence with Okamoto. Okamoto is Japan's lead
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