Aurobindo Pharma today said it has received the US health regulator's approval to sell its generic Levofloxacin injection, used to treat infections, in the American market.
The company has received final approval from the US Food and Drug Administration (USFDA) to manufacture and market Levofloxacin injection in strength of 25mg/ml, packaged in 500mg/20ml and 750mg/30ml single-use vials, Aurobindo Pharma said in a statement.
The company's product is generic equivalent of Janssen Pharmaceuticals Inc's Levaquin injection and is indicated for the treatment of adults with mild, moderate, and severe infections, it added.
Aurobindo now has a total of 175 abbreviated new drug (ANDA) approvals from the USFDA, the company said.
Shares of Aurobindo were trading at Rs 187.90 on the BSE in late afternoon trade, up 1.76 per cent from their previous close.
