American Pharmaceutical Partners Inc has received approvals from the U.S. Food and Drug Administration (FDA) for the Abbreviated New Drug Applications (ANDAs) of tobramycin sulfate injection, USP, the generic equivalent of Nebcin marketed by Eli Lilly and Company, and bacitracin, USP, the generic equivalent of Paddock Laboratories's bacitracin product. APP expects to begin marketing tobramycin as well as bacitracin in 2003.
APP also announced that its board of directors authorized the additional purchase, from time to time, of up to $20 million of the company's common stock through open market purchases and privately negotiated transactions.
Patrick Soon-Shiong, chairman, president and chief executive officer, said, "We have established a solid track record of gaining product approvals at a steady pace and these two new products bring to 10 the number of FDA approvals in 2002. Since 2000, we have obtained 27 generic injectable product approvals, which we believe is a record number in under three years."
Tobramycin is indicated for the treatment of serious bacterial infections caused by susceptible strains of the designated microorganisms in the following diseases: septicemia; lower respiratory tract infections; serious central-nervous-system infections; intra-abdominal infections; skin, bone, and skin structure infections; and complicated and recurrent urinary tract infections.
Bacitracin is limited for use in infants with staphylococcal pneumonia and empyema when these infections are a result of organisms shown to be susceptible to bacitracin.