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Synthon, Perrigo gain US FDA nod for generic allergy drug, winning first-to-file status

This article was originally published in Scrip

Executive Summary

Perrigo's shares got a slight 2.1% boost, or $1.80, on 18 May after its partner Synthon Pharmaceuticals won approval from the US FDA on their abbreviated new drug application (ANDA) for Levocetirizine solution, a generic version of UCB's Xyzal, a histamine H1-receptor antagonist indicated for the relief of symptoms associated with seasonal and perennial allergic rhinitis and as a treatment for uncomplicated skin manifestations of chronic idiopathic urticaria.



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