Merck (MRK), known as MSD outside the U.S. and Canada, reported the regulatory approval and launch of GRASTEK tablets in Canada, representing the first approval of GRASTEK for Merck. Currently, the product is marketed by ALK-Abello in Europe as GRAZAX.
Previously, Merck announced that the U.S. Food and Drug Administration or FDA had accepted for review Biologics License Applications for GRASTEK and for its investigational ragweed sublingual allergy immunotherapy tablet. The FDA's review for both are expected to be completed in the first half of 2014.
Merck has teamed up 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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