Uriach receives Health Canada approval for rupatadine

Publicado por en 25 Jul, 2016 en Noticias | Sin comentarios

Uriach’s international growth has been boosted by approval of rupatadine in Canada, including both tablets and the paediatric solution, for patients with allergic rhinitis and urticaria. This is the culmination of a joint project with Pediapharm, a pharmaceutical company specialising in paediatric products, which began with the signing of the licensing agreement in 2014. The agreement established a series of development milestones spanning from the preparation and submission of the registration dossier to the approval and subsequent marketing of rupatadine. Uriach will manufacture the medicinal product at its production site in Palau-solità i Plegamans.

Rupatadine will benefit from eight and a half years of market exclusivity granted by Health Canada’s Office of Patented Medicines. The antihistamine market in Canada, where rupatadine will be sold, is worth an estimated $130 mn. It will be the first prescription antihistamine to be launched in the last decade with such a solid clinical evidence base for all forms of allergic rhinitis and urticaria, with formulations for children aged 2 years or more and adults and adolescents.

The Uriach CEO Oriol Segarra pointed out that «pursuing our expansion on the international market and increasing rupatadine’s worldwide presence are two of the company’s strategic objectives, and this milestone is a key step in that direction. We started in 2014 with a far-reaching agreement in Japan, the biggest antihistamine market in the world, and we are closing 2016 with Canadian approval to sell the product on the Canadian market jointly with Pediapharm. In short, we are very pleased with this new step because we think Pediapharm has the necessary experience, resources and know-how to make rupatadine successful  in Canada».

The new agreement boosts the internationalisation of Uriach, which already sells its products in over 70 countries around the world.

Source: Uriach.com

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