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Merck & Co Inc announces FDA approves Grastek sublingual tablet for treatment of grass Pollen-Induced Allergic Rhinitis


Monday, 14 Apr 2014 05:59pm EDT 

Merck & Co Inc:U.S. Food and Drug Administration (FDA) has approved GRASTEK (Timothy Grass Pollen Allergen Extract) Tablet for Sublingual Use [2800 Bioequivalent Allergy Units (BAU)].GRASTEK is 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.GRASTEK is not indicated for immediate relief of allergic symptoms.Prescribing information for GRASTEK includes 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.Says or hypersensitivity to any of inactive ingredients contained in 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 grass pollen season. 

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