Ivax Corp. gained FDA approval to market cefaclor extended-release tablets 500 mg. Cefaclor extended-release tablets are indicated for the treatment of mild-to-moderate infections caused by susceptible organisms, including otitis media, lower respiratory tract infections, pharyngitis and tonsillitis, urinary tract infections, and skin and skin structure infections. Ivax is the first company to receive approval for its generic cefaclor. It will be marketed by Zenith Gold-line Pharmaceuticals. The branded product, Ceclor CD tablets, was originally developed and marketed by Eli Lilly, but is now exclusively marketed by Dura Pharmaceuticals. Annual sales of Ceclor CD in the United States are approximately $50 million.
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