Merck & Co. reports that FDA has approved Grastek ® (Timothy grass pollen allergen extract) for sublingual Use [2800 Bioequivalent Allergy Units (BAU)].

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. It is approved for use in persons from age five through 65 years of age.

Ragwitek is manufactured for Merck, Sharp & Dohme Corp., (a subsidiary of Merck and Co., Inc., Whitehouse Station, N.J.) by Catalent Pharma Solutions Limited, United Kingdom.

Source: Merck & Co. and FDA