FDA approves Abraxis' ANDA for generic combo antibiotic
Los Angeles, USA-based Abraxis BioScience has received approval from the Food and Drug Administration for its Abbreviated New Drug Application for the combination drug ampicillin and sulbactam for injection, 15g, USP, the latter compound being the generic equivalent of Pfizer's Unasyn.
According to IMS data, annual sales in 2005 of Unasyn exceeded $10.4 million. The company's hospital-based products division, Abraxis Pharmaceutical Products, expects to commence marketing ampicillin and sulbactam 15g immediately.
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