US FDA Approves Lannett Generic Xyzal Oral Solution

Lannett Company announced that it received approval from the US Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for levocetirizine dihydrochloride oral solution, 2.5 mg/5 mL (0.5 mg/mL), the therapeutic equivalent to the reference listed drug, Xyzal oral solution, 2.5 mg/5 mL (0.5 mg/mL), of UCB Inc. "The approval of levocetirizine dihydrochloride oral solution expands our line of oral generic drugs," said Arthur Bedrosian, chief executive officer of Lannett. "Our levocetirizine dihydrochloride oral solution will be manufactured in Carmel, New York by our wholly owned subsidiary, Silarx Pharmaceuticals."

Levocetirizine dihydrochloride oral solution is indicated for the relief of symptoms associated with perennial allergic rhinitis in children 6 months to 2 years of age and for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 months of age and older.