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Alk Abello A/S announces FDA approval for Merck’s grass sublingual allergy immunotherapy tablet GRASTEK (GRAZAX)


Monday, 14 Apr 2014 05:55pm EDT 

Alk Abello A/S:Announces that the US Food and Drug Administration (FDA) has approved the Biologic License Application (BLA) for Merck’s grass sublingual allergy immunotherapy (SLIT) tablet GRASTEK.GRASTEK is the US trade name of the grass SLIT-tablet which is licensed to Merck (known as MSD outside the USA and Canada) for North America by ALK, and marketed in Europe under the brand name GRAZAX.GRASTEK is an allergen extract.In the USA, GRASTEK is 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 the immediate relief of allergic symptoms. 

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