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FDA approves Stallergenes' Oralair

April 3, 2014 12:46 AM UTC

FDA approved Oralair from Stallergenes S.A. (Euronext:GENP) to treat grass pollen-induced allergic rhinitis with or without conjunctivitis in people aged 10-65 years. The U.S. approval triggers a $10 million milestone payment to Stallergenes from U.S. commercialization partner Greer Laboratories Inc. (Lenoir, N.C.). Greer plans to launch Oralair in May, but said pricing has not yet been determined for the tablet-based sublingual allergen immunotherapy against five grass allergens. The label includes a black box warning on the risk of severe allergic reactions. ...