ABBOTT FILES BIAXIN NDA IN USA
Abbott Laboratories has filed a New Drug Application with the US Food and Drug Administr-ation for a pediatric formulation of its macrolide antibiotic Biaxin (clarithromycin). The formulation is already approved in 14 countries, and is under regulatory review in a further 19.
Abbott is seeking approval for the following: acute otitis media, pharyngitis and tonsillitis, pneumonia, and skin and skin structure infections. Pediatric antibiotics have shown a compound growth rate in the USA of 18% over the last five years, with 1991 sales reaching $750 million.
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