Aurobindo Pharma Limited, a Hyderabad based manufacturer of generic pharmaceuticals and active pharmaceutical ingredients, has received final approvals from the US Food & Drug Administration (US FDA) for two ANDAs namely, ceftazidime for injection USP 500mg, 1g and 2g per vial and ceftazidime for injection USP 6g (Pharmacy Bulk Pack) per vial.
Ceftazidime for injection USP 500mg, 1g and 2g per vial and ceftazidime for injection USP 6g (Pharmacy Bulk Pack) per vial are sterile cephalosporin product under the anti-infective segment and generic equivalent to GlaxoSmithKline's Reference Listed Drug Fortaz for injections USP ceftazidime for injection USP 500mg, 1g and 2g per vial and ceftazidime for injection USP 6g (Pharmacy Bulk Pack) per vial.
Ceftazidime for injection is indicated for treatment of infections caused by susceptible gram - negative bacilli, e.g. septicemia, lower respiratory tract infections, abdominal cavity and biliary tract infections, complex urinary tract infections, serious skin soft tissue infections etc.
According to a company release, the product has a market size of approximately US$ 30million (Newport as of December 2009) and is ready for launch. The company now has a total of 119 ANDA approvals (89 final approvals and 30 tentative approvals) from US FDA.