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Maruho Succeeds Marketing Approval for Anti-Atopic Dermatitis Agent "Protopic® Ointment" in Japan

July 7, 2017

Osaka and Tokyo (Japan), July 7, 2017 – Maruho Co., Ltd (“Maruho”, Head Office: Osaka, Japan, President and CEO: Koichi Takagi) and Astellas Pharma Inc. (“Astellas”; Head Office: Tokyo, President and CEO: Yoshihiko Hatanaka) announce that from October 1, 2017, Maruho will succeed the marketing approval in Japan from Astellas, for anti-atopic dermatitis agent Protopic® Ointment 0.1% and Protopic® Ointment 0.03% for Pediatric (INN: tacrolimus hydrate, hereinafter referred to as “Protopic® Ointment”).


Protopic® Ointment was first approved in Japan in June 1999 with its anti-inflammatory action as a therapeutic agent for atopic dermatitis and launched in Japan in November 1999 by Fujisawa Pharmaceutical Co., Ltd. (currently Astellas). It is currently used in over 75 countries worldwide*. Maruho was assigned detailing/promotional activities in Japan for Protopic® Ointment in April 2011. Distribution rights in Japan for Protopic® Ointment were transferred to Maruho in April 2014. From October 2017, Maruho will provide and collect information as the manufacturer and distributor of Protopic® Ointment in Japan and will ensure a stable supply of this product.

*Transferred to LEO Pharma A/S outside Japan


As a pharmaceutical company specializing in dermatology, Maruho hopes to further contribute to patients suffering from atopic dermatitis through the succession of marketing approval for Protopic® Ointment.


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