First-Time Generic Approvals: Allegra-D 12 Hour
Start
On April 14, the FDA approved a first-time generic formulation of fexofenadine HCl plus pseudoephedrine HCl 60-mg/120-mg extended-release tablets (made by Barr Laboratories, Inc.; brand name Allegra-D 12 Hour, made by Aventis Pharmaceuticals, Inc.).
The antihistamine-decongestant combination is indicated for the relief of symptoms associated with seasonal allergic rhinitis in adults and children aged six years or older. It is also indicated for the treatment of uncomplicated skin manifestations of chronic idiopathic urticaria in this population.