- September 28, 2016
- Taiho Pharmaceutical Co., Ltd.
Taiho Pharmaceutical Receives Approval to Manufacture and Market Bilanoa® Tablets, an Oral Anti-allergy Drug in Japan
Taiho Pharmaceutical Co., Ltd. announced today that it has received approval in Japan from the Ministry of Health, Labour and Welfare to manufacture and market “Bilanoa® Tablets 20 mg”, (generic name: bilastine), an oral anti-allergy drug for the indications of allergic rhinitis, urticaria, and itching resulting from skin diseases (eczema/dermatitis and cutaneous pruritus).
This product is an innovative second-generation anti-histamine product, discovered by Faes Farma S.A. in Spain (HQ: Leioa, President: Mariano Ucar Angulo,"Faes Farma"). It has been approved in over 100 countries and regions* and marketed by several partners under the license from Faes Farma for the treatment of allergic rhinitis and urticaria.
Taiho has further developed the drug after signing a license agreement with Faes Farma in July 2012 for the development and marketing rights in Japan. In November 2015, it applied for manufacturing and marketing approval. In December 2015, Taiho Pharmaceutical and Meiji Seika Pharma Co., Ltd. (HQ: Tokyo, President and Representative Director: Daikichiro Kobayashi) signed a co-marketing agreement in Japan for the product. Now that approval has been granted, the two companies will engage in drug information provision and marketing.
Taiho will dedicate its effort to further contribute to patients and medical care providers for the treatment of allergic disorders.
* As of May 2016 (latest)
About Faes Farma S.A.
Faes Farma S.A. is one of the leading Spanish pharmaceutical companies, focused on research, manufacture and commercialization of innovative medicines.
With strong presence also in Portugal, Latin America and Africa, Faes Farma is now developing an intense process of internationalization. Bilastine shall be a key element in this process. For more information about Faes Farma, please visit the company's website at http://faesfarma.com/
Summary of the Approval
|Brand name||Bilanoa® Tablets 20 mg|
|Indications||Allergic rhinitis, urticaria, and itching resulting from skin diseases (eczema/dermatitis and cutaneous pruritus)|
|Use & Dosage||Normally, for adults, oral administration on an empty stomach of 20 mg of bilastine once daily|
Information in this news release was current as of the original release date.