Abraxis BioScience, Inc., an integrated, global biopharmaceutical company, has received approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for the combination drug Ampicillin and Sulbactam for Injection, 15g, USP, the generic equivalent of Pfizer Inc.'s Unasyn.
According to IMS data, annual sales in 2005 of this product exceeded $10.4 million. The company's hospital-based products division, Abraxis Pharmaceutical Products (APP), expects to commence marketing Ampicillin and Sulbactam, 15g immediately.
With this approval, APP now offers the complete line of Ampicillin and Sulbactam, which includes the 15g pharmacy bulk pack (PBP) and 1.5g and 3g single-dose vials (SDV). The product is AP rated and latex-free. The approval is the tenth product approval the company has received this year.
Ampicillin and Sulbactam is an injectable antibacterial combination consisting of the seminsynthetic antibiotic ampicillin sodium and the beta-lactamase inhibitor sulbactam sodium. Administered intravenously or intramuscular, Ampicillin and Sulbactam is indicated for the treatment of several skin and skin structure, intra-abdominal and gynaecological infections due to susceptible strains of microorganisms.
APP manufactures and markets one of the largest anti-infective injectable product portfolios and one of the broadest portfolios of oncology and critical care injectable products. APP, with its 350 dosage forms currently manufactured and marketed, the ten FDA approvals received in 2006, and the 26 ANDA's currently under review by the FDA, is positioned to be one of the largest suppliers of injectable pharmaceutical products for critically ill patients.