PARIS — Sanofi-Aventis and its U.S. consumer healthcare division Chattem on Tuesday afternoon announced the Food and Drug Administration has approved the Allegra (fexofenadine HCl) family of allergy medication products for over-the-counter use in adults and children 2 years of age and older.
Products will be on store shelves in March, the companies announced.
“Leveraging our U.S. consumer healthcare platform to convert prescription medicines to OTC products is a key growth driver for Sanofi-Aventis," stated Hanspeter Spek, Sanofi president of global operations. “The approval of Allegra for OTC use in the United States further validates our vision to increase our presence in the U.S. consumer healthcare market.”
The Allegra switch has been one of the reasons behind Sanofi’s acquisition of Chattem, which afforded the company both a toehold in the U.S. consumer health arena and a team of experienced executives to help shepherd the antihistamine to market.
The Allegra allergy remedy takes its place alongside the two other second-generation anthihistamines, Zyrtec and Claritin, which generated $222.9 million and $169.1 million, respectively, across food, drug and mass (excluding Walmart) over the 52 weeks ended Dec. 26, 2010, according to SymphonyIRI Group data.
Sales of Allegra over the first half of 2010 totaled $103.2 million, down 56.5% largely due to generic competition. Perrigo’s president, CEO and chairman, Joe Papa, has told analysts in the past that it is Perrigo’s intention to have a store-brand version of Allegra (fexofenadine) not too long after any switch application is approved.