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ABBOTT FILES NEW DRUG APPLICATION FOR PEDIATRIC ANTIBIOTIC

 ABBOTT FILES NEW DRUG APPLICATION FOR PEDIATRIC ANTIBIOTIC
 ABBOTT PARK, Ill., Aug. 25 /PRNewswire/ -- Abbott Laboratories announced today it has filed a New Drug Application (NDA) with the United States Food and Drug Administration for a pediatric formulation of its macrolide antibiotic Biaxin (clarithromycin).
 Abbott will seek approval for the following indications: acute otitis media, pharyngitis/tonsillitis, pneumonia and skin and skin structure infections. Otitis media is a middle ear infection common among young children.
 Pediatric antibiotics have experienced a compound growth rate in the United States of 18 percent over the last five years. In 1991, sales in the United States were approximately $750 million.
 Abbott's adult oral version of clarithromycin has received excellent market acceptance following its approval in the United States and 43 other countries around the world. The pediatric formulation of clarithromycin is currently approved in 14 countries, including Italy, Germany, Mexico and Japan, and is awaiting approval in 19 others.
 "We have experience with the pediatric formulation in over 1,700 patients from clinical trials," said Andre Pernet, Ph.D., vice president, pharmaceutical development. "Treatment of pediatric infections presents a number of challenges including resistant strains of bacteria, recurring infections and the prevalence of otitis media."
 Abbott licensed clarithromycin from Taisho Pharmaceuticals Company. The NDA filing is for an oral suspension in two strengths, with twice- daily dosing. Many of the current therapies are administered three or four times a day.
 Abbott Laboratories is a worldwide manufacturer of health care products employing 47,000 people. In 1991, the company's sales and net earnings were $6.9 billion and $1.1 billion, respectively, with earnings per share of $1.27.
 -0- 8/25/92
 /CONTACT: Matt Kuhn of Abbott Laboratories, 708-937-2993/
 (ABT) CO: Abbott Laboratories ST: Illinois IN: MTC SU:


GK -- NY042 -- 3040 08/25/92 12:34 EDT
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Publication:PR Newswire
Date:Aug 25, 1992
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