Aurobindo Pharma Limited has said that it has received final approvals from the US Food & Drug Administration for two ANDAs - injectible ampicillin with 125mg. 250mg, 500mg, 1g and 2g per vial USP and injectible ampicillin 10g for pharmacy bulk pack.
Ampicillin for injection USP is a sterile semi-synthetic penicillin (SSP) product under the anti-infective segment and is generic equivalent to Sandoz's reference listed drug ampicillin for injections USP, which is indicated in the treatment of infections caused by susceptible strains of the designated organisms in conditions such as respiratory tracts infections, bacterial meningitis, septicemia and endocarditis, urinary tract and gastrointestinal infections, etc.
The product has a market size of approximately $45 million according to IMS as of June 2009 and is ready for launch.
These are the first product approvals of Unit XII, a penicillin sterile injectable formulation facility situated in Hyderabad, India by USFDA.
Aurobindo now has a total of 123 ANDA approvals (93 final approvals and 30 tentative approvals) from USFDA