City-based generic drug maker Aurobindo Pharma today said it has received final approval from the US Food and Drug Administration (USFDA) to manufacture and market Piperacillin and Tazobactam injections.
This would be packaged in single use vials in quantities of 2.25g, 3.375g and 4.5g.
Piperacillin and Tazobactam injections consists of a semi-synthetic penicillin and a beta-lactamase inhibitor.
It is prescribed for the treatment of moderate to severe systemic and or local bacterial infections and complicated urinary tract infections (including pyelonephritis.
It is also used to treat intra-abdominal infections, skin and soft tissue infections, bacterial infections in neutropenic adults and bacterial infections in neutropenic children aged 2-12 years.
As per IMS data, the product had a market size of around $635 million for the 12 months ended September 30 last year.
Aurobindo Piperacillin and Tazobactam is the third generic product approved in the US.
Aurobindo now has a total of 136 Abbreviated New Drug Application (ANDA) approvals (105 Final approvals and 31 Tentative approvals) from USFDA.
