Perrigo announced that its partner, Teva Pharmaceutical Industries, Ltd. has received final OTC approval to sell and distribute fexofenadine HCl 60 mg and 180 mg tablets; the generic equivalents of Sanofi-Aventis’ Allegra 60 mg and 180 mg products. Teva has had Rx approval for these products, and Teva and Sanofi-Aventis have settled their Paragraph IV/Hatch-Waxman litigation relating to the Allegra brand family of products.
Allegra 60 mg and 180 mg tablets are indicated for the temporary relief of symptoms associated with indoor and outdoor allergies. Chattem, Inc., a wholly-owned U.S. subsidiary of Sanofi-Aventis, launched Allegra 60 mg and 180 mg tablets in retail stores on March 3, 2011 as part of their Rx to OTC switch of the Allegra brand. Perrigo expects to begin distributing fexofenadine 60 mg and 180 mg tablets to its wholesale and retail customers under their store brand labels immediately.
Perrigo’s chairman and CEO Joseph C Papa stated, “This is a particularly important example of Perrigo’s strategic focus and execution of making quality healthcare more affordable to American consumers by introducing new store brand versions of important Rx-to-OTC switch products. We look forward to working with our retail and wholesale customers to grow these new store brand products as important components in their retail allergy categories.”
Perrigo company is a leading global healthcare supplier that develops, manufactures and distributes OTC and generic prescription pharmaceuticals, nutritional products, infant formula, Active Pharmaceutical Ingredients (API) and consumer products.