FDA clears APP's Polmyxin B Sulfate
US specialty drug developer APP Pharmaceuticals has received Food and Drug Administration approval for its Polmyxin B Sulfate injection product for the treatment of acute infections caused by Pseudeomonas aeruginosa. This is a generic version of Bradford Laboratories' product. The firm said that it intends to begin marketing the drug, which is formulated to contain 500,000 units/vial, in the next few months.
The Schaumburg, Illinois-headquartered firm also announced that it has launched its granisetron HCl product for the prevention of the nausea and vomiting associated with chemotherapy. The drug, which is available as a 0.1mg/ml, 1ml single vial formulation, is a generic version of Roche's Kyrtil (granisetron) which, according to data from IMS Health, achieved sales of $3.3 million in 2007.
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