Drug company Aurobindo Pharma on Saturday said it has received final approval from the US Food and Drug Administration (US FDA) to sell anti-biotic Ampicillin injection in the US.
The approvals are for Ampicillin injection 125 mg, 250 mg, 500 mg, 1 gram and 2 gram per vial and Ampicillin injection 10 gram (pharmacy bulk pack) per vial, the company said in a statement.
The drug is the generic equivalent to Sandoz Inc's reference listed drug Ampicillin for injection USP. "There is a market size of approximately USD 45 million for the product as of June 2009, according to IMS", the company said in a statement adding that it is ready to launch the product in the US market.
It is used in treatment of infections of respiratory, urinary and gastrointestinal tracts, bacterial meningitis, septicemia and endocarditis.
Aurobindo now has 93 final Abbreviated New Drug Application (ANDA) approvals and 30 tentative approvals from the US FDA. The company manufactures generic drugs and active pharmaceutical ingredients and markets these products in over 125 countries.