Aurobindo Pharma Ltd announced that the company has received final approval from the US Food and Drug Administration (US FDA) to manufacture and market piperacillin and tazobactam for injection 2.25g, 3.375g and 4.5g, packaged in single use vials.
Piperacillin and tazobactam for injection 2.25g, 3.375g and 4.5g are the generic equivalent of Wyeth’s Zosyn injection 2.25g, 3.375g and 4.5g. Piperacillin and tazobactam for injection consists of a semi-synthetic penicillin and a beta-lactamase inhibitor and is indicated for the treatment of moderate to severe systemic and local bacterial infections in which betalactamase producing bacteria are suspected or have been detected, such as nosocomial pneumonia, complicated urinary tract infections, intra-abdominal infections, skin and soft tissue infections, bacterial infections in neutropenic adults and bacterial infections in neutropenic children aged 2-12 years.
It has a market size of approximately US$ 635 million for the twelve months ending September 2010 according to IMS and will be launched soon. Aurobindo piperacillin and tazobactam is the third generic product approved in the US.