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ALLEGAN, Mich. — Perrigo announced that its partner Teva Pharmaceutical Industries Ltd. has received final approval to sell and distribute fexofenadine HCl allergy relief tablets over the counter.
Perrigo said Wednesday that Teva has been cleared to market fexofenadine HCl 60 mg and 180 mg tablets, the generic equivalents of sanofi-aventis’ Allegra 60 mg and 180 mg products.
Teva has had prescription 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, according to Perrigo.
Allegra 60 mg and 180 mg tablets are indicated for the temporary relief of symptoms associated with indoor and outdoor allergies. Perrigo reported that Chattem Inc., a U.S. subsidiary of sanofi-aventis, launched Allegra 60 mg and 180 mg tablets in retail stores on March 3 as part of its Rx-to-OTC switch of the Allegra brand.
Plans call for Perrigo to begin distributing fexofenadine 60 mg and 180 mg tablets to its wholesale and retail customers under their store brand labels immediately.
"This is a particularly important example of Perrigo’s strategic focus and execution of making quality health care more affordable to American consumers by introducing new store-brand versions of important Rx-to-OTC switch products," Perrigo chairman and chief executive officer Joseph Papa said in a statement. "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."
