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news.Galderma Pharma has announced that Japan's Ministry of Health, Labor and Welfare has approved Differin gel 0.1%, a novel topical treatment for acne vulgaris in Japan.
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Galderma’s Differin gel 0.1% will be marketed in Japan by Galderma KK, the fully-owned Japanese arm of Galderma, and strategic alliance partner Shionogi.
Approval was based on non-clinical and clinical studies, which supported the efficacy and safety of the product for the registration outside Japan and on an extensive local clinical development program, including two Phase III studies enrolling more than 600 Japanese patients.
According to the agreement between both firms, Galderma and Shionogi will co-promote Differin gel 0.1% with their respective sales forces and Shionogi will have sales and distribution rights for the product for a period of eight years.
Commercialization will begin once the product is listed on the National Health Insurance reimbursement list, a process that is expected to be complete by autumn 2008.