WHITEHOUSE STATION (dpa-AFX) - Merck & Co. Inc. (MRK) said Monday that the U.S. Food and Drug Administration has approved Grastek Tablet for Sublingual Use.
Grastek is an allergen extract indicated as immunotherapy for the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis confirmed by positive skin test or in vitro testing for pollen-specific IgE antibodies for Timothy grass or cross-reactive grass pollens. Grastek is approved for use in persons 5 through 65 years of age. It is not indicated for the immediate relief of allergic symptoms.
The prescribing information for Grastek includes a boxed warning regarding severe allergic reactions. Grastek is contraindicated in patients with severe, unstable or uncontrolled asthma; a history of any severe systemic allergic reaction; a history of any severe local reaction after taking any sublingual allergen immunotherapy; a history of eosinophilic esophagitis; or hypersensitivity to any of the inactive ingredients contained in the product.
Symptoms of grass pollen-induced allergic rhinitis with or without conjunctivitis may include sneezing, runny or itchy nose, stuffy or congested nose, or itchy and watery eyes, and typically intensify during the grass pollen season.
Grastek will be available in U.S. pharmacies in late April.
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