Merck, known as MSD outside the United States and Canada, has received regulatory approval and launch of Grastek (Timothy grass pollen allergen extract) sublingual tablets in Canada. This represents the first approval of Grastek for Merck. The product is currently marketed by ALK-Abello in Europe as Grazax.
Merck previously announced that the US Food and Drug Administration (FDA) had accepted for review Biologics License Applications for Grastek and for its investigational ragweed sublingual allergy immunotherapy tablet. Merck expects the FDA’s review for both to be completed in the first half of 2014.
Merck has partnered with ALK-Abello to develop its sublingual allergy immunotherapy tablets for Timothy grass pollen, ragweed pollen and house dust mite-induced allergic rhinitis in North America.
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